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Express News | Shanghai Junshi Biosciences - Regular Approval of Toripalimab as Second-Line or Later Treatment of Melanoma by Nmpa
JUNSHI BIO (688180.SH): Trelagliptin for second-line and above treatment of melanoma has obtained regular approval from the National Medical Products Administration.
On January 6th, Gloronghui reported that JUNSHI BIO (688180.SH) announced that it received the "Pharmaceutical Supplement Application Approval Notification" issued by the National Medical Products Administration (referred to as "National Drug Administration"). The indication for Trepulimab (trade name: Tuoyi, product code: JS001) for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy has been agreed by the National Drug Administration, and its conditional approval has been converted to regular approval.
Highly resilient! Leading CRO companies have stabilized their fundamentals, but the shadow of the biosafety bill may still linger next year | Year-end review.
① In 2024, the USA Biodefense Act will disrupt CROs throughout the year and may continue next year; ② In the first three quarters of this year, over half of listed companies experienced revenue growth, and leading CROs demonstrated resilience; ③ Research on popular targets such as ADC, GLP-1, and bispecific antibodies will continue to be hot; ④ In 2025, the performance of leading CROs and small to medium enterprises may further diverge.
JUNSHI BIO (01877.HK) elected Li Zhongxian and Lu Kun as independent non-executive Directors.
On December 20, Gelonghui reported that JUNSHI BIO (01877.HK) announced that the Board of Directors is pleased to announce that the resolution regarding the election of Li Zhongxian as an independent non-executive director has been approved at the extraordinary general meeting of shareholders held on December 20, 2024. The election of Li Zhongxian as an independent non-executive director became effective on the day of the extraordinary general meeting (i.e., December 20, 2024). The resolution regarding the election of Lu Kun as an independent non-executive director has also been approved at the extraordinary general meeting of shareholders held on December 20, 2024.
The U.S. bioterrorism law has undergone significant changes, the CRO concept has launched a major counterattack, and WuXi AppTec is excited!
Industry pessimistic expectations may improve.
How to break through the challenges in the development of innovative drugs? The industry suggests focusing on internationalization.
① The year 2024 will be the inaugural year of large-scale authorized trade, and going abroad has become an important direction for the development of local pharmaceutical companies; ② Chinese企业品牌, clinical trial capabilities, data presentation formats, and levels of international operation still need time and practical verification.
Further Weakness as Shanghai Junshi Biosciences (HKG:1877) Drops 3.2% This Week, Taking Three-year Losses to 83%
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