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先声药业(02096.HK):创新管线持续推进 对外授权进展顺利
Ge Long Hui· 2025-06-26 02:51
Company Updates - The company announced on June 20 that its new generation insomnia drug, Kewike (Dazodex), has been approved by the National Medical Products Administration for the treatment of adult insomnia characterized by difficulty in falling asleep and/or maintaining sleep, and it is not classified as a controlled substance [1] - Kewike has demonstrated excellent clinical data, addressing existing clinical pain points, and has potential as a blockbuster drug (BIC). It has been approved in 11 countries including the US, UK, Switzerland, and Hong Kong, and is the only DORA class insomnia drug approved by the European Medicines Agency to improve daytime functioning, with good safety profile and no withdrawal reactions or addiction data [1] - The company recently reached a supplemental agreement with Idorsia, agreeing to a one-time cash payment of $50 million and reducing sales milestone payments and royalty rates for Kewike, which is expected to facilitate its commercialization [1] Strategic Collaborations - The company announced a strategic collaboration with NextCure on June 16 to jointly develop SIM0505 (CDH6 ADC), granting global rights outside Greater China to NextCure. The company will receive up to $745 million in related payments during the potential development phase and tiered royalties based on net sales in the licensed regions [2] - SIM0505 utilizes the company's proprietary TOPOi payload and has shown strong anti-tumor effects in various solid tumor models during preclinical studies. It is currently undergoing Phase I clinical trials in China, with NextCure planning to initiate Phase I trials in the US in Q3 2025 [2] Clinical Development - The company completed the first patient dosing in the US for its self-developed tri-antibody SIM0500 (GPRC5D/BCMA/CD3) on June 18. This drug is developed based on the company's proprietary T-cell engaging multi-specific antibody platform and received Fast Track designation from the FDA in April 2024 [2] - A licensing option agreement was reached with AbbVie in 2025, with total milestone payments reaching $1.055 billion. The company has a rich pipeline of ADC and TCE platforms, and attention is recommended on the clinical progress of several early-stage products [2] Financial Forecast and Valuation - The company maintains its earnings forecast for 2025/2026, with the current stock price corresponding to 21.8x/19.5x P/E for 2025/2026. Considering the upward trend in sector valuations, the target price has been raised by 45.5% to HKD 12.8, corresponding to 24.9x/22.3x P/E for 2025/2026, implying a 14.1% upside potential [2]