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ALPHAMAB-B (09966.HK): The IND application for a Phase I/II clinical trial of JSKN033 has been approved by CDE.
On December 24, Gelonghui announced that ALPHAMAB-B (09966.HK) has received approval from the National Medical Products Administration ("NMPA") Drug Evaluation Center ("CDE") for its new drug clinical trial application ("IND") for JSKN033 (a high concentration subcutaneous combined formulation of HER2 bispecific antibody conjugate drug ("ADC") and PD-L1 immune checkpoint inhibitor). JSKN033-102 is an open-label, multi-center, phase I/II clinical trial.
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.
[Brokerage Focus] Soochow Securities issues a ‘Buy’ rating for Corning Incorporated (09966), noting that the differentiated pipeline layout is gradually entering a harvest period.
Jingu Finance News | Soochow Securities released a research report stating that Corning Jiere Pharmaceutical (09966) is a leading biopharmaceutical company in China. The actual controller, Dr. Xu Ting, holds 33.01% of the company's shares. The equity structure is stable, and the management team is experienced. The company has now transformed into dual-antibody ADC development, building an industry-leading glycosylation point coupling technology, with a complete patent layout. The process is simple and the coupling is stable. This platform has been recognized by the international pharmaceutical company ArriVent, reaching a cooperation agreement to jointly apply this platform for the development of subsequent ADC products. Several new products of the company are in development, involving TROP2, EGFR,
Alphamab Oncology's (HKG:9966) Largest Shareholder, CEO Ting Xu Sees Holdings Value Fall by 12% Following Recent Drop
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.
Alphamab Oncology's (HKG:9966) 31% Dip Still Leaving Some Shareholders Feeling Restless Over Its P/SRatio
