20231029-安信证券-新药周观点_君实PD-1美国获批_国产创新药出海即将进入新阶段_15页_1mb

Anxin Securities Biomed II Industry Weekly Report Summary

Key Highlights

• Date and Focus: This week's report (October 29, 2023) covers the Biomed II industry, emphasizing new drug developments, international expansion, and regulatory updates for Chinese pharmaceutical companies.

• New Drug Market Performance: The new drug sector saw significant volatility, with top gainers including Di Zhi Pharmaceutical (+1940%) and Kanou De Inc (+1836%), while losers like Tennis Sheng药业 (-1530%) dragged down the market.

• Major Event Analysis: Johnson & Johnson's (Coherus) approval of tislelizumab for nasopharyngeal cancer in the US marks a milestone, making it the first Chinese PD-1 drug approved by the FDA. This signals a new phase in Chinese drug internationalization, with several other products like bavbesiran and carotimab in review.

• FDA and Licensing Updates: Over 30 overseas licensing deals occurred in 2023, highlighting increased collaboration opportunities. Key drugs in FDA审理 include ticagrelor, pexidinib, and heroninib for various cancers and metabolic disorders.

• Recent Drug Approvals: This week, three new drugs or indications were approved in China, 28 IND applications were filed, and 27 INDs and three NDA filings were submitted, reflecting active R&D activity.

• Domestic and Global Focus: Notable events include Di Zhi's data on savoritinib for EGFR-mutated lung cancer, Huanyong Hanlin's partnership for immunotherapy rights, and overseas developments like AstraZeneca's datopotamabderuxtecan for Trop2-targeting ADC therapy.

• Risk Factors: Potential delays in clinical trials, regulatory changes, and patent disputes pose risks to the sector's growth.

Bottom Line

The report underscores a turning point for Chinese biomed innovations in overseas markets, with robust pipeline advancements and high-risk rewards in clinical and commercial stages.