Current landscape of innovative drug development and regulatory support in China
Open accessAbstract
The global pharmaceutical landscape remains dynamic and competitive, shaped by advancements in first-in-class therapies and breakthrough technologies. The United States has maintained its leadership in first-in-class therapies and breakthrough technologies, driven by advanced regulatory pathways, significant multinational corporation investments, a robust Research and Development (R&D) workforce, and continuous technological innovation. Additionally, global impact of the Food and Drug Administration (FDA) is further amplified through collaborations like Project Orbis, which facilitates simultaneous reviews of cancer treatments by multiple regulatory authorities worldwide. Europe, while historically strong, faces growing challenges in maintaining its competitive edge, particularly due to protracted regulatory timelines and complex coordination among its member states. In this competitive global environment, China has rapidly transformed from a generics-dominated market to a key player in innovative drug development. This article reviews China’s progress in innovative drug R&D from 2019 to 2023, emphasizing regulatory modernization, clinical trial advancements, and the emergence of novel therapies. By comparing China’s developments with above global counterparts, this review highlights the country’s achievements in regulatory efficiency, clinical trial progress, and the development of innovative therapies such as biologics and cell and gene therapies. Through this comparative analysis, the article underscores how China’s evolving policy-driven innovation ecosystem has positioned it as a growing leader in global drug development. The review examines how enhanced regulatory efficiency, clinical trial progress, manufacturing capabilities, and international collaboration have bolstered China’s growing influence, while also discussing the future opportunities and challenges it faces in shaping global pharmaceutical innovation and development.
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China's National Medical Products Administration has updated and strengthened its Technical Guidelines for Biological Drug Development, including cell and gene therapy products, to align with Quality of Biotechnological Products standards.
“China’s National Medical Products Administration (NMPA) has updated and strengthened its “Technical Guidelines for Biological Drug Development”, including cell and gene therapy products to align with the Quality of Biotechnological Products standards [97].”
From Genetic Insights into the Economic Toll of Cell Line Misidentification: A Comprehensive Review (2026) · cites this paper as [97]
The Introduction and the section on regulatory measures describe NMPA regulatory modernization and adoption of ICH guidelines. The section on innovative-drug classification also reports revised registration classifications for biologics. Our copy does not say that NMPA updated the named “Technical Guidelines for Biological Drug Development,” that those guidelines include cell and gene therapy products, or that they were aligned with “Quality of Biotechnological Products” standards. (LLM, conf=0.84)
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Cites
Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.
Munshi, N. C., Anderson, L. D., Shah, N., Madduri, D., Berdeja, J., Lonial, S., Raje, N., Lin, Y., Siegel, D., Oriol, A., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2024850 · Cited by 2,560 · see citing works
Abramson, J. S., Palomba, M. L., Gordon, L. I., Lunning, M. A., Wang, M., Arnason, J., Mehta, A., Purev, E., Maloney, D. G., Andreadis, C., et al. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31366-0 · Cited by 2,430 · see citing works
Sotorasib for Lung Cancers with <i>KRAS</i> p.G12C Mutation
Skoulidis, F., Li, B. T., Dy, G. K., Price, T. J., Falchook, G. S., Wolf, J., Italiano, A., Schuler, M., Borghaei, H., Barlesi, F., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2103695 · Cited by 1,849 · see citing works
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol
Ray, K. K., Wright, R. S., Kallend, D., Koenig, W., Leiter, L. A., Raal, F. J., Bisch, J. A., Richardson, T., Jaros, M., Wijngaard, P. L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1912387 · Cited by 1,665 · see citing works
Vericiguat in patients with heart failure and reduced ejection fraction
Armstrong, P. W., Pieske, B., Anstrom, K. J., Ezekowitz, J., Hernandez, A. F., Butler, J., Lam, C. S. P., Ponikowski, P., Voors, A. A., Jia, G., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1915928 · Cited by 1,358 · see citing works
Lecanemab: Appropriate Use Recommendations
Cummings, J., Apostolova, L., Rabinovici, G. D., Atri, A., Aisen, P., Greenberg, S., Hendrix, S., Selkoe, D., Weiner, M., Petersen, R. C., et al. (2023) · The Journal of Prevention of Alzheimer's Disease · doi:10.14283/jpad.2023.30 · Cited by 961 · see citing works
Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma
Nathan, P., Hassel, J. C., Rutkowski, P., Baurain, J.-F., Butler, M. O., Schlaak, M., Sullivan, R. J., Ochsenreither, S., Dummer, R., Kirkwood, J. M., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2103485 · Cited by 924 · see citing works
Tanriover, M. D., Doğanay, H. L., Akova, M., Güner, H. R., Azap, A., Akhan, S., Köse, Ş., Erdinç, F. Ş., Akalın, E. H., Tabak, Ö. F., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(21)01429-x · Cited by 898 · see citing works
Swanson, C. J., Zhang, Y., Dhadda, S., Wang, J., Kaplow, J., Lai, R. Y. K., Lannfelt, L., Bradley, H., Rabe, M., Koyama, A., et al. (2021) · Alzheimer's Research & Therapy · doi:10.1186/s13195-021-00813-8 · Cited by 847 · see citing works
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia
Raal, F. J., Kallend, D., Ray, K. K., Turner, T., Koenig, W., Wright, R. S., Wijngaard, P. L. J., Curcio, D., Jaros, M. J., Leiter, L. A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913805 · Cited by 818 · see citing works
de Langen, A. J., Johnson, M. L., Mazieres, J., Dingemans, A.-M. C., Mountzios, G., Pless, M., Wolf, J., Schuler, M., Lena, H., Skoulidis, F., et al. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00221-0 · Cited by 619 · see citing works
Sotorasib plus Panitumumab in Refractory Colorectal Cancer with Mutated <i>KRAS</i> G12C
Fakih, M. G., Salvatore, L., Esaki, T., Modest, D. P., Lopez-Bravo, D. P., Taieb, J., Karamouzis, M. V., Ruiz-Garcia, E., Kim, T.-W., Kuboki, Y., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2308795 · Cited by 398 · see citing works
Pieske, B., Maggioni, A. P., Lam, C. S. P., Pieske-Kraigher, E., Filippatos, G., Butler, J., Ponikowski, P., Shah, S. J., Solomon, S. D., Scalise, A.-V., et al. (2017) · European Heart Journal · doi:10.1093/eurheartj/ehw593 · Cited by 366 · see citing works
FDA Approval Summary: Sotorasib for <i>KRAS G12C</i> -Mutated Metastatic NSCLC
Nakajima, E. C., Drezner, N., Li, X., Mishra-Kalyani, P. S., Liu, Y., Zhao, H., Bi, Y., Liu, J., Rahman, A., Wearne, E., et al. (2022) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-21-3074 · Cited by 333 · see citing works
Ray, K. K., Troquay, R. P. T., Visseren, F. L. J., Leiter, L. A., Scott Wright, R., Vikarunnessa, S., Talloczy, Z., Zang, X., Maheux, P., Lesogor, A., et al. (2023) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00353-9 · Cited by 328 · see citing works
Evinacumab in Patients with Refractory Hypercholesterolemia
Rosenson, R. S., Burgess, L. J., Ebenbichler, C. F., Baum, S. J., Stroes, E. S. G., Ali, S., Khilla, N., Hamlin, R., Pordy, R., Dong, Y., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2031049 · Cited by 302 · see citing works
Dhillon, S. (2021) · Drugs · doi:10.1007/s40265-021-01569-z · Cited by 293 · see citing works
Koga, T., Suda, K., Fujino, T., Ohara, S., Hamada, A., Nishino, M., Chiba, M., Shimoji, M., Takemoto, T., Arita, T., et al. (2021) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2021.04.015 · Cited by 265 · see citing works
An overview of FDA-approved new molecular entities: 1827–2013
Kinch, M. S., Haynesworth, A., Kinch, S. L., & Hoyer, D. (2014) · Drug Discovery Today · doi:10.1016/j.drudis.2014.03.018 · Cited by 210 · see citing works
Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities
Vaz, M., Silva, V., Monteiro, C., & Silvestre, S. (2022) · Clinical Interventions in Aging · doi:10.2147/cia.s325026 · Cited by 183 · see citing works
Ray, K. K., Stoekenbroek, R. M., Kallend, D., Nishikido, T., Leiter, L. A., Landmesser, U., Wright, R. S., Wijngaard, P. L. J., & Kastelein, J. J. P. (2019) · JAMA Cardiology · doi:10.1001/jamacardio.2019.3502 · Cited by 172 · see citing works
Rosenson, R. S., Gaudet, D., Ballantyne, C. M., Baum, S. J., Bergeron, J., Kershaw, E. E., Moriarty, P. M., Rubba, P., Whitcomb, D. C., Banerjee, P., et al. (2023) · Nature Medicine · doi:10.1038/s41591-023-02222-w · Cited by 140 · see citing works
Self-citationReeskamp, L. F., Millar, J. S., Wu, L., Jansen, H., van Harskamp, D., Schierbeek, H., Gipe, D. A., Rader, D. J., Dallinga-Thie, G. M., Hovingh, G. K., et al. (2021) · Arteriosclerosis, Thrombosis, and Vascular Biology · doi:10.1161/atvbaha.120.315204 · Cited by 109 · see citing works
Kuboki, Y., Fakih, M., Strickler, J., Yaeger, R., Masuishi, T., Kim, E. J., Bestvina, C. M., Kopetz, S., Falchook, G. S., Langer, C., et al. (2024) · Nature Medicine · doi:10.1038/s41591-023-02717-6 · Cited by 103 · see citing works
Inclisiran: a new promising agent in the management of hypercholesterolemia
Kosmas, C. E., Muñoz Estrella, A., Sourlas, A., Silverio, D., Hilario, E., Montan, P. D., & Guzman, E. (2018) · Diseases · doi:10.3390/diseases6030063 · Cited by 99 · see citing works
Albosta, M. S., Grant, J. K., Taub, P., Blumenthal, R. S., Martin, S. S., & Michos, E. D. (2023) · Vascular Health and Risk Management · doi:10.2147/vhrm.s338424 · Cited by 51 · see citing works
Artificial intelligence in European medicines regulation
Hines, P. A., Herold, R., Pinheiro, L., Frias, Z., & Arlett, P. (2023) · Nature Reviews Drug Discovery · doi:10.1038/d41573-022-00190-3 · Cited by 24 · see citing works
Flagged first, then by citations
Research works printed but not linked: 518
- [1]Zheng, L., Wang, W. & Sun, Q. Targeted drug approvals in 2023: breakthroughs by the FDA and NMPA. Signal Transduction Targeted Ther. 9, 46 (2024). PMC10879080 38378623 · DOI
- [2]Shmela, M. & Habbassi, M. Overview in EMA and FDA approved novel drugs in thE YEARS 2020, 2021 and 2022. Libyan. J. Med. 18, 178–192 (2024). · DOI
- [3]Scott, E. C. et al. Trends in the approval of cancer therapies by the FDA in the twenty-first century. Nat. Rev. Drug Discov. 22, 625–640 (2023). 37344568 · DOI
- [4]Kinch, M. S., Kraft, Z. & Schwartz, T. 2023 in review: FDA approvals of new medicines. Drug Discov. Today. 29, 103966 (2024). 38552777 · DOI
- [5]Rim, M. H., Barada, F. & Levitsky, A. M. Recent and anticipated novel drug approvals for 2023 and 2024. Am. J. Health Syst. Pharm. 80, 1729–1732 (2023). 37688502 · DOI
- [7]Thakkar, S. et al. Artificial intelligence and real-world data for drug and food safety—a regulatory science perspective. Regul. Toxicol. Pharmacol. 140, 105388 (2023). 37061083 · DOI
- [8]Michaeli, D. T. et al. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. Eur. J. Health. Econ. 25, 979–997 (2024). 37962724 PMC11283430 · DOI
- [9]Wong, A. K. et al. Use of expedited regulatory programs and clinical development times for FDA-approved novel therapeutics. JAMA Netw. Open. 6, e2331753 (2023). 37651145 PMC10472182 · DOI
- [10]Brown, D. G. A Drug discovery perspective on FDA expedited development and incentive programs. J. Med. Chem. 67, 1690–1700 (2024). 38233132 · DOI
- [11]Benjamin, D. J. & Lythgoe, M. P. Modernising the US FDA’s accelerated approval pathway. Lancet Oncol 24, 203–205 (2023). 36858720 · DOI
- [12]Franco, P. et al. Regulatory pathways supporting expedited drug development and approval in ICH member countries. Ther. Innov. Regul. Sci. 57, 484–514 (2023). 36463352 PMC9734413 · DOI
- [13]Ghadanian, M. & Schafheutle, E. Comparison between European Medicines Agency and US Food and Drug Administration in granting accelerated marketing authorizations for Covid-19 medicines and their utilized regulations. Ther. Innov. Regul. Sci. 58, 79–113 (2024). 37861859 PMC10764419 · DOI
- [14]de Claro, R. A. et al. Project Orbis: global collaborative review program. Clin. Cancer Res. 26, 6412–6416 (2020). 33037016 · DOI
- [15]Beca, J. et al. HPR161 international comparisons of health technology assessment and reimbursement outcomes for oncology drugs with regulatory review through project Orbis. Value Health 26, S238 (2023). · DOI
- [16]Tibau, A. & Kesselheim, A. S. Global cooperation and early access—clinical outcomes matter. Lancet Oncol 25, 687–688 (2024). 38754452 · DOI
- [17]Arora, S. et al. FDA approval summary: pembrolizumab plus lenvatinib for endometrial carcinoma, a collaborative international review under project orbis. Clin. Cancer Res. 26, 5062–5067 (2020). 32295834 · DOI
- [18]Koch, A. L. et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non–small cell lung cancer, a Collaborative Project Orbis Review. Clin. Cancer Res. 27, 6638–6643 (2021). 34301748 · DOI
- [19]Jenei, K., Gentilini, A., Haslam, A. & Prasad, V. Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis. Lancet Oncol 25, 979–988 (2024). 39004098 · DOI
- [21]Ncube, B. M., Dube, A. & Ward, K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J. Pharm. Policy Pract. 14, 29 (2021). 33685518 PMC7938385 · DOI
- [22]Abdulwahab, A. A. et al. The African Medicines Agency and Medicines Regulation: Progress, challenges, and recommendations. Health Care Sci 3, 350–359 (2024). 39479274 PMC11520252 · DOI
- [23]Ogbodum, M. U. et al. African Medicines Agency: How it will change the landscape of medicines in Africa. Public Health Chall 2, e96 (2023). 40495871 PMC12039615 · DOI
- [24]Hwenda, L., Sidibe, M. & Makanga, M. The African Medicines Agency: the key to unlocking clinical research in Africa. Lancet Glob. Health. 10, e1088–e1089 (2022). 35716676 · DOI
- [25]Chattu, V. K. et al. Advancing African Medicines Agency through global health diplomacy for an equitable pan-African universal health coverage: a scoping review. Int. J. Env. Res. Public Health. 18, 11758 (2021). 34831511 PMC8621302 · DOI
- [26]Kong, L., Li, Q., Kaitin, K. I. & Shao, L. Innovation in the Chinese pharmaceutical industry. Nat. Rev. Drug Discov. 22, 12–13 (2023). 36303035 · DOI
- [30]Liu, Y. et al. Evolution of drug regulations and regulatory innovation for anticancer drugs in China. Acta Pharm. Sin. B. 12, 4365–4377 (2022). 36561995 PMC9764065 · DOI
- [31]Tang, W. et al. Evolving drug regulatory landscape in China: a clinical pharmacology perspective. Clin. Transl. Sci. 14, 1222–1230 (2021). 33503308 PMC8301550 · DOI
- [33]NMPA. NMPA Held 2023 ICH in China: Progress and Outlook Symposium < https://english.nmpa.gov.cn/2023-09/13/c_963948.htm> (2023).
- [34]NMPA. NMPA holds symposium on process and prospects of ICH in China < https://english.nmpa.gov.cn/2021-04/10/c_610224.htm#:~:text=China%27s%20drug%20regulatory%20authority%20joined%20the%20ICH%20in,member%20of%20the%20ICH%20Management%20Committee%20in%202018> (2021).
- [36]Lu, J., Xu, L., Wei, W. & He, W. Advanced therapy medicinal products in China: regulation and development. MedComm 4, e251 (2023). 37125239 PMC10133728 · DOI
- [37]Zhu, Q. et al. Expedited program and utilization for anticancer drug approval in China and the United States. Chin. J. Oncol. 46, 904–910 (2024). 39293993
- [40]Tan, R. et al. Redefining chimeric antigen receptor T-cell (CAR-T) regulation: China’s responses to address secondary cancer risks of CAR-T therapy. J. Hematol. Oncol. 17, 90 (2024). 39380046 PMC11462758 · DOI
- [41]Wang, S. et al. The landscape of cell and gene therapies for solid tumors. Cancer Cell 39, 7–8 (2021). 33434513 · DOI
- [44]Li, G. et al. Evolution of innovative drug R&D in China. Nat. Rev. Drug Discov. 21, 553–554 (2022). 35365768 · DOI
- [45]Luo, X. et al. Clinical benefit, price, and regulatory approval of cancer drugs granted breakthrough therapy designation in China, 2020-2024. JAMA Netw. Open. 7, e2439080 (2024). 39412805 PMC11581593 · DOI
- [46]Arciero, V. et al. Assessment of Food and Drug Administration–and European Medicines Agency–approved systemic oncology therapies and clinically meaningful improvements in quality of life: a systematic review. JAMA Netw. Open. 4, e2033004 (2021). 33570573 PMC7879236 · DOI
- [47]Lythgoe, M. et al. Time intervals between US Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals. J. Clin. Oncol. 39, 15 (2021). · DOI
- [48]Gnanasakthy, A. et al. A review of labeling based on patient-reported outcome endpoints for new oncology drugs approved by the European medicines agency (2017–2021). Value Health 26, 893–901 (2023). 36746305 · DOI
- [50]Opinions on Reforming the Review and Approval System for Drugs and Medical Devices < https://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm> (2015).
- [58]Brown, D. G. & Wobst, H. J. A decade of FDA-approved drugs (2010–2019): trends and future directions. J. Med. Chem. 64, 2312–2338 (2021). 33617254 · DOI
- [59]Pevarello, P. Recent drug approvals from the US FDA and EMEA: what the future holds. Future Med. Chem. 1, 35–48 (2009). 21426069 · DOI
- [60]SSRN. FDA’s Approvable and Related NDA/BLA Actions < https://ssrn.com/abstract=1105509> (2008).
- [61]Branch, S. K. & Agranat, I. “New drug” designations for new therapeutic entities: New active substance, new chemical entity, new biological entity, new molecular entity. J. Med. Chem. 57, 8729–8765 (2014). 25188028 · DOI
- [62]Griesenauer, R. H. & Kinch, M. S. 2016 in review: FDA approvals of new molecular entities. Drug Discov. Today. 22, 1593–1597 (2017). 28687460 · DOI
- [63]Kinch, M. S. & Griesenauer, R. H. 2018 in review: FDA approvals of new molecular entities. Drug Discov. Today. 24, 1710–1714 (2019). 31158510 PMC7580227 · DOI
- [64]Kinch, M. S. & Griesenauer, R. H. 2017 in review: FDA approvals of new molecular entities. Drug Discov. Today. 23, 1469–1473 (2018). 29751111 · DOI
- [65]Cross, J. et al. Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980–1999. Pharmacoepidemiol. Drug Saf. 11, 439–446 (2002). 12426927 · DOI
- [72]Hemphill, T. A. Biologics regulation, second-to-market competition, and the use of blockchain technology: an opportunity for the FDA to support responsible biotechnology innovation. J. Respons. Innov. 7, 689–696 (2020). · DOI
- [73]Chang, L.-C., Mahmood, R., Qureshi, S. & Breder, C. D. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications. PLoS One 12, e0178104 (2017). 28570569 PMC5453490 · DOI
- [74]Lau, S. J. et al. Participation of older adults in clinical trials for new drug applications and biologics license applications from 2010 through 2019. JAMA Netw. Open. 5, e2236149 (2022). 36239939 PMC9568796 · DOI
- [75]Kinch, M. S. An overview of FDA-approved biologics medicines. Drug Discov. Today. 20, 393–398 (2015). 25220442 · DOI
- [76]Arondekar, B. et al. Real-world evidence in support of oncology product registration: a systematic review of new drug application and biologics license application approvals from 2015–2020. Clin. Cancer Res. 28, 27–35 (2022). 34667027 PMC9401526 · DOI
- [77]Rogstad, S. et al. A retrospective evaluation of the use of mass spectrometry in FDA biologics license applications. J. Am. Soc. Mass Spectrom. 28, 786–794 (2016). 27873217 · DOI
- [78]Purpura, C. A. et al. The role of real‐world evidence in FDA‐approved new drug and biologics license applications. Clin. Pharmacol. Ther. 111, 135–144 (2022). 34726771 PMC9299054 · DOI
- [80]Annemans, L., Cleemput, I., Hulstaert, F. & Simoens, S. Valorising and creating access to innovative medicines in the European Union. Front. Pharmacol. 2, 57 (2011). 22013421 PMC3190181 · DOI
- [81]Motola, D. et al. An update on the first decade of the European centralized procedure: how many innovative drugs? Br. J. Clin. Pharmacol. 62, 610–616 (2006). 16796703 PMC1885166 · DOI
- [82]Bergmann, L. et al. Access to innovative oncology medicines in Europe. Ann. Oncol. 27, 353–356 (2016). 26578739 PMC4722892 · DOI
- [83]Vallano, A., Pontes, C. & Agustí, A. The challenges of access to innovative medicines with limited evidence in the European Union. Front. Pharmacol. 14, 1215431 (2023). 37719853 PMC10500193 · DOI
- [84]Enzmann, H. New trends and challenges in the European regulation of innovative medicines. Regul. Toxicol. Pharmacol. 80, 314–320 (2016). 27237379 · DOI
- [85]Goldman, M. The innovative medicines initiative: a European response to the innovation challenge. Clin. Pharmacol. Ther. 91, 418–425 (2012). 22318619 · DOI
- [86]Kondo, H. et al. The current status of Sakigake designation in Japan, PRIME in the European Union, and breakthrough therapy designation in the United States. Ther. Innov. Regul. Sci. 51, 51–54 (2017). 30235998 · DOI
- [87]Joppi, R. et al. Food and Drug Administration vs European Medicines Agency: review times and clinical evidence on novel drugs at the time of approval. Br. J. Clin. Pharmacol. 86, 170–174 (2020). 31657044 PMC6983504 · DOI
- [88]Mullard, A. PRIME time at the EMA. Nat. Rev. Drug Discov. 16, 226–228 (2017). 28356591 · DOI
- [89]Antoñanzas, F., Juárez-Castelló, C. & Rodríguez-Ibeas, R. EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data? Eur. J. Health Econ. 19, 905–907 (2018). 29188395 · DOI
- [90]Neez, E., Hwang, T. J., Sahoo, S. A. & Naci, H. European Medicines Agency’s priority medicines scheme at 2 years: an evaluation of clinical studies supporting eligible drugs. Clin. Pharmacol. Ther. 107, 541–552 (2020). 31591708 · DOI
- [91]Boucaud-Maitre, D. & Altman, J.-J. Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006–2015: a cohort study. Eur. J. Clin. Pharmacol. 72, 1275–1281 (2016). 27473682 · DOI
- [92]Parviainen, L. et al. Early market access for pharmaceuticals in EU: what is the impact of EMA’s accelerated assessment procedure? Value Health 19, A469 (2016). · DOI
- [102]Lapteva, L. & Pariser, A. R. Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold. J. Investig. Med. 64, 376–382 (2016). 26911627 · DOI
- [103]Giannuzzi, V., Altavilla, A., Ruggieri, L. & Ceci, A. Clinical trial application in Europe: what will change with the new regulation? Sci. Eng. Ethics. 22, 451–466 (2016). 26037896 · DOI
- [104]Eder, C. & Wild, C. Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption. J. Mark. Access Health Policy. 7, 1600939 (2019). 31069029 PMC6493298 · DOI
- [111]VanHelene, A. D. et al. As bleak as it sounds? Analysing trends in oncology clinical trial initiation in the UK from 2010 to 2022. BMJ Oncol. 3, e000410 (2024). 39886121 PMC11347684 · DOI
- [112]Lasch, F. et al. The impact of COVID‐19 on the initiation of clinical trials in Europe and the United States. Clin. Pharmacol. Ther. 111, 1093–1102 (2022). 35090044 PMC9015398 · DOI
- [113]Capone, G. et al. Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape. Nat. Rev. Drug Discov. 23, 797–798 (2024). 38783027 · DOI
- [118]Wang, W. & Sun, Q. Novel targeted drugs approved by the NMPA and FDA in 2019. Signal Transduct. Target. Ther. 5, 65 (2020). 32385226 PMC7205905 · DOI
- [120]Ali, S. & Zhou, J. Highlights on US FDA-approved fluorinated drugs over the past five years (2018–2022). Eur. J. Med. Chem. 256, 115476 (2023). 37207534 PMC10247436 · DOI
- [121]Michaeli, D. T. & Michaeli, T. Breakthrough therapy cancer drugs and indications with FDA approval: development time, innovation, trials, clinical benefit, epidemiology, and price. J. Natl. Compr. Canc. Netw. 22, 237110 (2024). 38648855 · DOI
- [122]Corrigan‐Curay, J. & Stein, P. FDA Breakthrough therapy designation–trial design and more–commentary. Clin. Pharmacol. Ther. 110, 869–870 (2021). 34389983 · DOI
- [123]Chandra, A., Kao, J., Miller, K. L. & Stern, A. D. Regulatory incentives for innovation: the FDA’s breakthrough therapy designation. Rev. Econ. Stat. 2024, 1–46 (2024). · DOI
- [124]Herink, M. C. et al. Pharmacists’ knowledge and perceptions of FDA approval standards and the breakthrough therapy designation. Pharmacy. 10, 126 (2022). 36287447 PMC9610476 · DOI
- [125]Lingaratnam, S. et al. Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review. J. Pharm. Policy and Pract. 17, 2389120 (2024). 39175661 PMC11340226 · DOI
- [126]Paquin, R. S., Boudewyns, V., O’Donoghue, A. C. & Aikin, K. J. Physician perceptions of the FDA’s breakthrough therapy designation: an update. Oncologist. 27, e85–e88 (2022). 35305103 PMC8842303 · DOI
- [127]Vokinger, K. N., Kesselheim, A. S., Glaus, C. E. & Hwang, T. J. in JAMA Health Forum. e222685 (American Medical Association). PMC9391955 36200635
- [128]Gyawali, B., Rome, B. N. & Kesselheim, A. S. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ. 374, n1959 (2021). 34497044 PMC8424519 · DOI
- [129]Gyawali, B., Ross, J. S. & Kesselheim, A. S. Fulfilling the mandate of the US Food and Drug Administration’s accelerated approval pathway: the need for reforms. JAMA Intern. Med. 181, 1275–1276 (2021). 34254981 · DOI
- [130]Cherla, A. et al. Assessment of coverage in England of cancer drugs qualifying for US Food and Drug Administration accelerated approval. JAMA Intern. Med. 181, 490–498 (2021). 33616607 PMC7900925 · DOI
- [131]Wahby, S. et al. FDA approval summary: accelerated approval of sacituzumab govitecan-hziy for third-line treatment of metastatic triple-negative breast cancer. Clin. Cancer Res. 27, 1850–1854 (2021). 33168656 · DOI
- [132]Choi, H. Y. & Chang, J.-E. Targeted therapy for cancers: from ongoing clinical trials to FDA-approved drugs. Int. J. Mol. Sci. 24, 13618 (2023). 37686423 PMC10487969 · DOI
- [133]Martins, A. C., Oshiro, M. Y., Albericio, F. & de la Torre, B. G. Food and Drug Administration (FDA) approvals of biological drugs in 2023. Biomedicines. 12, 1992 (2024). 39335511 PMC11428688 · DOI
- [134]Moon, H. et al. FDA regulatory considerations for oncology drug development. Pharmacol. Res. Perspect. 12, e1254 (2024). 39075638 PMC11286537 · DOI
- [135]Kluetz, P. G. et al. FDA oncology center of excellence project renewal: engaging the oncology community to update product labeling for older oncology drugs. Clin. Cancer Res. 27, 916–921 (2021). 33257426 · DOI
- [136]Feinberg, B. A. et al. Use of real-world evidence to support FDA approval of oncology drugs. Value Health 23, 1358–1365 (2020). 33032780 · DOI
- [137]Duke, E. S. et al. Highlights of FDA oncology approvals in 2022: tissue-agnostic indications, dosage optimization, and diversity in drug development. Cancer Discov 12, 2739–2746 (2022). 36458428 · DOI
- [138]Walia, A., Haslam, A. & Prasad, V. FDA validation of surrogate endpoints in oncology: 2005–2022. J. Cancer Policy. 34, 100364 (2022). 36155118 · DOI
- [139]Katz, R. FDA: evidentiary standards for drug development and approval. NeuroRx. 1, 307–316 (2004). 15717032 PMC534930 · DOI
- [140]Papapetropoulos, A. et al. Novel drugs approved by the EMA, the FDA, and the MHRA in 2023: a year in review. Br. J. Pharmacol. 181, 1553–1575 (2024). 38519837 · DOI
- [141]Xia, Y. et al. Synthetic routes and clinical application of new drugs approved by EMA during 2023. Eur. J. Med. Chem. 277, 116762 (2024). 39151275 · DOI
- [142]Lythgoe, M. P. et al. From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit. Lancet Oncol 24, e150–e160 (2023). 36990613 · DOI
- [147]Sevigny, J. et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature. 537, 50–56 (2016). 27582220 · DOI · Paper page
- [148]Cummings, J. et al. Aducanumab: appropriate use recommendations. J. Prev. Alzheim. 8, 398–410 (2021). PMC8835345 34585212 · DOI · Paper page
- [149]Walsh, S., Merrick, R., Milne, R. & Brayne, C. Aducanumab for Alzheimer’s disease? BMJ. 374, n1682 (2021). 34226181 PMC8258645 · DOI
- [151]Van Dyck, C. H. et al. Lecanemab in early Alzheimer’s disease. N. Engl. J. Med. 388, 9–21 (2023). 36449413 · DOI · Paper page
- [153]Chowdhury, S. & Chowdhury, N. S. Novel anti-amyloid-beta (Aβ) monoclonal antibody lecanemab for Alzheimer’s disease: a systematic review. Int. J. Immunopath. Ph. 37, 03946320231209839 (2023). PMC10617290 37902139
- [154]Walsh, S. et al. Lecanemab for Alzheimer’s disease. BMJ. 379, 3010 (2022). 36535691 · DOI · Paper page
- [155]Qiao, Y., Chi, Y., Zhang, Q. & Ma, Y. Safety and efficacy of lecanemab for Alzheimer’s disease: a systematic review and meta-analysis of randomized clinical trials. Front. Aging Neurosci. 15, 1169499 (2023). 37213538 PMC10196238 · DOI
- [156]Lythgoe, M. P., Jenei, K. & Prasad, V. Regulatory decisions diverge over aducanumab for Alzheimer’s disease. BMJ. 376, e069780 (2022). 35091420 · DOI
- [157]Mahase, E. Lecanemab: European drug agency rejects Alzheimer’s drug amid debate over efficacy and safety. BMJ. 386, q1692 (2024). 39074878 · DOI
- [159]Lythgoe, M. P. & Sullivan, R. Outsourcing UK regulatory decisions—a double-edged sword? Lancet. 402, 24–25 (2023). 37393100 · DOI
- [160]Wu, S. et al. A review of the research report on the high-quality development of China’s pharmaceutical industry (2021–2023). CFDA Mag. 4–17, (2024).
- [161]Chen, Z. et al. Chinese innovative drug R&D trends in 2024. Nat. Rev. Drug Discov. 2024, 0731 (2024).
- [162]Luscombe, E. Is being the first ever ‘better’than being the best? Expert Opin. Pharmacother. 15, 1–2 (2014). 24666337 · DOI
- [163]Agten, S. & Wu, B. in Biopharma in China: Innovation, Trends and Dealmaking 71–99 (Springer, 2024).
- [164]Betz, U. A. How many genomics targets can a portfolio afford? Drug Discov. Today. 10, 1057–1063 (2005). 16055022 · DOI
- [165]Schulze, U. & Ringel, M. What matters most in commercial success: first-in-class or best-in-class? Nat. Rev. Drug Discov. 12, 419 (2013). 23722339 · DOI
- [166]Munos, B. A forensic analysis of drug targets from 2000 through 2012. Clin. Pharmacol. Ther. 94, 407–411 (2013). 23756372 · DOI
- [167]Stocks, M. in Introduction to Biological and Small Molecule Drug Research and Development 81–126 (Elsevier, 2013).
- [168]Nakano, T. et al. Performance evaluation of leader–follower-based mobile molecular communication networks for target detection applications. IEEE Trans. Commun. 65, 663–676 (2016). · DOI
- [169]Jiang, Y., Liu, Z., Holenz, J. & Yang, H. Competitive intelligence–based lead generation and fast follower approaches. Lead Gen 2016, 183–220 (2016). · DOI
- [170]Sams-Dodd, F. Research & market strategy: how choice of drug discovery approach can affect market position. Drug Discov. Today. 12, 314–318 (2007). 17395091 · DOI
- [171]Aronson, J. K. & Green, A. R. Me‐too pharmaceutical products: history, definitions, examples, and relevance to drug shortages and essential medicines lists. Br. J. Clin. Pharmacol. 86, 2114–2122 (2020). 32358800 PMC7576625 · DOI
- [172]Régnier, S. What is the value of ‘me-too’drugs? Health Care Manage. Sci 16, 300–313 (2013). 23440390 · DOI
- [173]Pekarsky, B. Should financial incentives be used to differentially reward ‘me-too’and innovative drugs? Pharmacoeconomics. 28, 1–17 (2010). 20014872 · DOI
- [175]Zhou, Z. et al. Revolutionising cancer immunotherapy: advancements and prospects in non‐viral CAR‐NK cell engineering. Cell Prolif 58, e13791 (2024). 39731215 PMC11969250 · DOI
- [176]Wang, Y. et al. Comparison of seven CD19 CAR designs in engineering NK cells for enhancing anti‐tumour activity. Cell Prolif 57, e13683 (2024). 38830795 PMC11533075 · DOI
- [177]Citeline. Citeline Pharma R&D Annual Review 2023 < https://www.citeline.com/en/resources/citeline-rd-annual-review-2023> (2023).
- [178]VBDATA.CN. 2023 Pharmaceutical R&D Annual Review: with 5402 pipelines, China has become the world’s second largest pharmaceutical research country < https://www.vbdata.cn/1518917850> (2023).
- [179]Lyu, X. et al. The global landscape of approved antibody therapies. Antib. Ther. 5, 233–257 (2022). 36213257 PMC9535261
- [180]Fu, Z. et al. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. Signal Transduct. Target. Ther. 7, 93 (2022). 35318309 PMC8941077 · DOI · Paper page
- [181]Jin, S. et al. Emerging new therapeutic antibody derivatives for cancer treatment. Signal Transduct. Target. Ther. 7, 39 (2022). 35132063 PMC8821599 · DOI
- [182]Shen, L. et al. ADCdb: the database of antibody–drug conjugates. Nucleic Acids Res 52, D1097–D1109 (2024). 37831118 PMC10768060 · DOI
- [183]Huang, Z., Li, J. & Zhang, M. in New Anti-cancer Drug Development and Evaluation 115–139 (Springer, 2024).
- [184]Ruan, D. Y., Wu, H. X., Meng, Q. & Xu, R. H. Development of antibody‐drug conjugates in cancer: overview and prospects. Cancer Commun 44, 3–22 (2024). PMC10794012 38159059 · DOI
- [185]Wang, V. et al. Systematic review on CAR-T cell clinical trials up to 2022: academic center input. Cancers. 15, 1003 (2023). 36831349 PMC9954171 · DOI
- [186]Wu, W. et al. Regulatory oversight of cell therapy in China: government’s efforts in patient access and therapeutic innovation. Pharmacol. Res. 158, 104889 (2020). 32428666 · DOI
- [188]Herink, M. C., Irwin, A. N. & Zumach, G. M. FDA breakthrough therapy designation: Evaluating the quality of the evidence behind the drug approvals. Pharmacotherapy. 38, 967–980 (2018). 30043413 · DOI
- [189]Aggarwal, S. A survey of breakthrough therapy designations. Nat. Biotechnol. 32, 323–330 (2014). 24714478 · DOI
- [190]Poddar, A., Raggio, M. & Concato, J. Decisions on non-oncology breakthrough therapy designation requests in 2017–2019. Ther. Innov. Regul. Sci. 58, 214–221 (2024). 37926768 PMC10764372 · DOI
- [191]Blumenthal, G. M. et al. Oncology drug approvals: evaluating endpoints and evidence in an era of breakthrough therapies. Oncologist. 22, 762–767 (2017). 28576856 PMC5507655 · DOI
- [192]Kern, K. A. Trial design and efficacy thresholds for granting breakthrough therapy designation in oncology. J. Oncol. Pract. 12, e810–e817 (2016). 27460496 · DOI
- [193]Shea, M. et al. Impact of breakthrough therapy designation on cancer drug development. Nat. Rev. Drug Discov. 15, 152–153 (2016). 26931085 · DOI
- [194]Yao, J. C., Meric-Bernstam, F., Lee, J. J. & Eckhardt, S. G. Accelerated approval and breakthrough therapy designation: oncology drug development on speed? Clin. Cancer Res. 19, 4305–4308 (2013). 23833307 PMC4167364 · DOI
- [195]Horning, S. J. et al. Developing standards for breakthrough therapy designation in oncology. Clin. Cancer Res. 19, 4297–4304 (2013). 23719260 PMC3745545 · DOI
- [197]Lythgoe, M. P. et al. Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010–2019. JAMA Netw. Open. 5, e2216183 (2022). 35687337 PMC9187952 · DOI
- [202]Singh, H. & Pazdur, R. Importing oncology trials from China: a bridge over troubled waters? Lancet Oncol 23, 323–325 (2022). 35131039 · DOI
- [203]Zhang, J. Z. In Biotechnology Entrepreneurship 567–582 (Elsevier, 2020).
- [204]Luo, X. et al. The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis. Lancet. Reg. Health. West. Pac. 32, 100670 (2023). 36785854 PMC9918802
- [205]Wang, S. et al. Evolution of early-phase anticancer drug investigations in China. JAMA Oncol 8, 1692–1694 (2022). 36074496 PMC9459900 · DOI
- [208]Williamson, J. & Spicer, A. J. Review of the impact of the FDA’s fast track designation on biotechnology companies’ share prices. Drug Discov. Today. 28, 103771 (2023). 37716502 · DOI
- [211]Zhu, X. & Chen, Y. Bridging the new drug access gap between China and the United States and its related policies. Front. Pharmacol. 14, 1296737 (2024). 38259295 PMC10800674 · DOI
- [212]Wei, Y. et al. Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001–2020. Lancet. Reg. Health. West. Pac. 45, 101055 (2024). 38590780 PMC10999698
- [213]Le, A. M. & Torres, T. New topical therapies for psoriasis. Am. J. Clin. Dermatol. 23, 13–24 (2022). 34705167 · DOI
- [214]Lu, S. T., Kelly, K. A. & Feldman, S. R. An overview of benvitimod for the treatment of psoriasis: a narrative review. Expert Opin. Pharmacother. 23, 327–333 (2022). 34937468 · DOI
- [215]Chen, L. et al. Application of benvitimod on psoriasis: a systematic review and meta-analysis of randomized controlled trials. A systematic review of benvitimod on psoriasis. Therapies 77, 339–347 (2022). 34689959 · DOI
- [216]Zhang, J., Cai, L. & Zheng, M. A novel topical treatment for plaque psoriasis: benvitimod/tapinarof. J. Am. Acad. Dermatol. 86, e137–e138 (2022). 34742862 · DOI
- [217]Ehsan, M. et al. Benvitimod for the treatment of psoriasis: a systematic review and meta‐analysis of randomized controlled trials. Dermatol. Ther. 35, e15957 (2022). 36279313 · DOI
- [218]Cai, L. et al. A double-blind, randomized, placebo-and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis. Chin. Med. J. 133, 2905–2909 (2020). 33177393 PMC7752683 · DOI
- [219]Huo, Y. et al. Efficacy and safety of tafolecimab in Chinese patients with non-familial hypercholesterolemia (CREDIT-1): a 48-week randomized, double-blind, placebo-controlled phase 3 trial. Circulation. 146, A10111–A10111 (2022). PMC10558773 37808342 · DOI
- [220]Cui, Y. et al. Tafolecimab, a novel potential long-acting PCSK9 monoclonal antibody: efficacy and safety in healthy and hypercholesterolemia subjects. Eur. Heart J. 41, ehaa946.3327 (2020). · DOI
- [221]Huo, Y. et al. Tafolecimab in Chinese patients with non-familial hypercholesterolemia (CREDIT-1): a 48-week randomized, double-blind, placebo-controlled phase 3 trial. Lancet. Reg. Health. West. Pac. 41, 100907 (2023). 37808342 PMC10558773
- [222]Qi, L. et al. Tafolecimab in Chinese patients with hypercholesterolemia (CREDIT-4) a randomized, double-blind, placebo-controlled phase 3 trial. JACC: Asia 3, 636–645 (2023). 37614541 PMC10442872
- [223]Keam, S. J. Tafolecimab: first approval. Drugs. 83, 1545–1549 (2023). 37847461 · DOI
- [224]Chai, M. et al. Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2). BMC Med 21, 77 (2023). 36855099 PMC9976471 · DOI
- [225]Xu, J. et al. Efficacy and safety of surufatinib in patients with well-differentiated advanced extrapancreatic neuroendocrine tumors (NETs): results from the randomized phase III study (SANET-ep). Ann. Oncol. 30, v911 (2019). · DOI
- [226]Chen, J. et al. Surufatinib in Chinese patients with locally advanced or metastatic differentiated thyroid cancer and medullary thyroid cancer: a multicenter, open-label, phase II trial. Thyroid. 30, 1245–1253 (2020). 32075524 · DOI
- [227]Xu, J. et al. Surufatinib in advanced well-differentiated neuroendocrine tumors: a multicenter, single-arm, open-label, phase Ib/II trial. Clin. Cancer Res. 25, 3486–3494 (2019). 30833272 · DOI
- [228]Dasari, A. et al. Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs). J. Clin. Oncol. 38, 4610–4610 (2020). · DOI
- [229]Xu, J. et al. A single‐arm, multicenter, open‐label phase 2 trial of surufatinib in patients with unresectable or metastatic biliary tract cancer. Cancer. 127, 3975–3984 (2021). 34355801 · DOI
- [230]Xu, J. et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 21, 1500–1512 (2020). 32966811 · DOI
- [231]Syed, Y. Y. Surufatinib: first approval. Drugs. 81, 727–732 (2021). 33788183 · DOI
- [232]Xu, J. Current treatments and future potential of surufatinib in neuroendocrine tumors (NETs). Ther. Adv. Med. Oncol. 13, 17588359211042689 (2021). 34484432 PMC8411625 · DOI
- [233]Koumarianou, A. & Kaltsas, G. Surufatinib—a novel oral agent for neuroendocrine tumours. Nat. Rev. Endocrinol. 17, 9–10 (2021). 33128026 · DOI
- [234]Xu, J. et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 21, 1489–1499 (2020). 32966810 · DOI
- [235]Qian, H. et al. Effects of food on the pharmacokinetic properties of surufatinib: a phase I, single-dose, randomized, open-label crossover study in healthy subjects. Clin. Ther. 42, 1778–1786 (2020). 32800383 · DOI
- [236]Wang, M. et al. 987 P Sunvozertinib for NSCLC patients with EGFR exon 20 insertion mutations: preliminary analysis of WU-KONG6, the first pivotal study. Ann. Oncol. 33, S1003–S1004 (2022). · DOI
- [238]Yang, J.-H. et al. 1325 P Sunvozertinib as first-line treatment in NSCLC patients with EGFR Exon20 insertion mutations. Ann. Oncol. 34, S765 (2023). · DOI
- [239]Hayashi, H. Sunvozertinib: the next candidate of TKI for NSCLC. Lancet Respir. Med. 12, 185–186 (2024). 38101435 · DOI
- [240]Dhillon, S. Sunvozertinib: first approval. Drugs. 83, 1629–1634 (2023). 37962831 · DOI
- [241]Yang, J.-H. et al. EP08. 02-029 sunvozertinib in NSCLC patients with EGFR Exon20 insertion mutations: effect of prior treatment. J. Thorac. Oncol. 17, S410–S411 (2022). · DOI
- [242]Wang, M. et al. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir. Med. 12, 217–224 (2024). 38101437 · DOI
- [243]Wang, M. et al. Sunvozertinib for the treatment of NSCLC with EGFR Exon20 insertion mutations: the first pivotal study results. J. Clin. Oncol. 41, 9002–9002 (2023). · DOI
- [244]Janne, P. A. et al. Antitumor activity of sunvozertinib in NSCLC patients with EGFR Exon20 insertion mutations after platinum and anti-PD (L) 1 treatment failures. J. Clin. Oncol. 40, 9015–9015 (2022). · DOI
- [245]Wang, M. et al. Sunvozertinib, a selective EGFR inhibitor for previously treated non–small cell lung cancer with EGFR exon 20 insertion mutations. Cancer Discov 12, 1676–1689 (2022). 35404393 PMC9262839 · DOI · Paper page
- [246]Kong, F. et al. Traditional Chinese medicines for non-small cell lung cancer: therapies and mechanisms. Chin. Herb. Med. 15, 509–515 (2023). 38094015 PMC10715886
- [247]Wong, A. H. P. et al. Impact of CD151 overexpression on prognosis and therapy in non‐small cell lung cancer patients lacking EGFR mutations. Cell Prolif 57, e13708 (2024). 38982031 PMC11503249 · DOI
- [248]Campbell, N., Kalabalik-Hoganson, J. & Frey, K. Vericiguat: a novel oral soluble guanylate cyclase stimulator for the treatment of heart failure. Ann. Pharmacother. 56, 600–608 (2022). 34431706 · DOI
- [249]Markham, A. Pralsetinib: first approval. Drugs. 80, 1865–1870 (2020). 33136236 · DOI
- [250]Griesinger, F. et al. Safety and efficacy of pralsetinib in RET fusion–positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial. Ann. Oncol. 33, 1168–1178 (2022). 35973665 · DOI
- [251]Gainor, J. F. et al. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol 22, 959–969 (2021). 34118197 · DOI
- [252]Kim, J. et al. FDA approval summary: pralsetinib for the treatment of lung and thyroid cancers with RET gene mutations or fusions. Clin. Cancer Res. 27, 5452–5456 (2021). 34045295 · DOI
- [253]Zhou, Q. et al. Efficacy and safety of pralsetinib in patients with advanced RET fusion‐positive non–small cell lung cancer. Cancer. 129, 3239–3251 (2023). 37282666 · DOI
- [254]Subbiah, V. et al. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol 9, 491–501 (2021). 34118198 PMC13224057 · DOI
- [255]Zhu, K.-W. Deuremidevir and simnotrelvir–ritonavir for the treatment of COVID-19. ACS Pharmacol. Transl. Sci. 6, 1306–1309 (2023). 37705591 PMC10496140 · DOI
- [256]Cao, B. et al. Oral Simnotrelvir for adult patients with mild-to-moderate covid-19. N. Engl. J. Med. 390, 230–241 (2024). 38231624 PMC11156186 · DOI
- [257]Yang, X.-M. et al. A first-in-human phase 1 study of simnotrelvir, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects. Eur. J. Pharm. Sci. 191, 106598 (2023). 37783378 · DOI
- [258]McCarthy, M. W. Simnotrelvir as a potential treatment for COVID-19. Expert Opin. Pharmacother. 25, 233–237 (2024). 38393345 · DOI
- [259]Wang, F. et al. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial. Lancet. Reg. Health. West. Pac. 38, 100838 (2023). 37484496 PMC10362366
- [260]Jiang, X. et al. Structure-based development and preclinical evaluation of the SARS-CoV-2 3C-like protease inhibitor simnotrelvir. Nat. Commun. 14, 6463 (2023). 37833261 PMC10575921 · DOI
- [261]Cao, Z. et al. VV116 versus nirmatrelvir–ritonavir for oral treatment of Covid-19. N. Engl. J. Med. 388, 406–417 (2023). 36577095 PMC9812289 · DOI
- [262]Zhu, K.-W. National Medical Products Administration (NMPA) approves deuremidevir (VV116) and simnotrelvir-ritonavir for mild to moderate COVID-19 in China. ACS Pharmacol. Transl. Sci. 6, 1306–1309 (2023). 37705591 PMC10496140 · DOI
- [263]Liu, W. et al. Remdesivir derivative VV116 is a potential broad-spectrum inhibitor of both human and animal coronaviruses. Viruses. 15, 2295 (2023). 38140536 PMC10748125 · DOI
- [265]Zhan, Y. et al. Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial. Eclinicalmedicine. 67, 102359 (2024). 38188690 PMC10770433 · DOI
- [266]Wang, K. et al. Model informed dose regimen optimizing in development of leritrelvir for the treatment of mild or moderate COVID-19. Front. Pharmacol. 15, 1449583 (2024). 39263567 PMC11387175 · DOI
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Genetic Insights into the Economic Toll of Cell Line Misidentification: A Comprehensive Review
Weiskirchen, R. (2026) · Medical Sciences · doi:10.3390/medsci14010025 · Cited by 4 · see citing works
- Authors
- Tan, R., Hua, H., Zhou, S., Yang, Z., Yang, C., Huang, G., Zeng, J., & Zhao, J.
- Affiliations
- National Medical Products Administration (CN)
- National Center for Nanoscience and Technology (CN)
- Corresponding author
- Zhao, Junning
- Venue
- Signal Transduction and Targeted Therapy
- Published
- 2025-07-22
- Volume
- 10
- Issue
- 1
- Pages
- 220-220
- ISSN
- 2059-3635 (ISSN-L)
- PMC
- PMC12280122
- OpenAlex
- W4412535332
- Cited by
- 51
- References
- 27
- Citations by year
- 2026: 44 · 2025: 7
- FWCI
- 13.93
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- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Signal Transduction and Targeted Therapy (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
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- PubMed (publishedVersion)
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- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Biotechnology and Related Fields
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- new drug development, drug regulation, regulatory modernization, clinical trials, biologics, cell and gene therapy, first-in-class therapy, regulatory efficiency, pharmaceutical industry competitiveness, China pharmaceutical industry, international regulatory cooperation
- MeSH terms
- Drug Development, China, Drug Industry, Humans, United States, United States Food and Drug Administration
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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