新药周观点：恒瑞双艾组合BLA重获FDA受理，国内创新药出海如火如荼

Investment Rating - The report maintains an investment rating of "Outperform" for the biopharmaceutical sector [6]. Core Insights - Recently, Heng Rui Medicine resubmitted its Biologics License Application (BLA) for Camrelizumab combined with Rivoceranib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, which has been officially accepted by the FDA [2][20]. - The domestic innovative drug export is thriving, with several innovative drugs already approved by the FDA, including drugs from companies like BeiGene and Legend Biotech, indicating a promising future for these products in the U.S. market [2][20]. - The report highlights that there are multiple biosimilars currently under FDA review, suggesting ongoing opportunities for growth in overseas markets [2][20]. Weekly New Drug Market Review - From October 14 to October 18, 2024, the top five companies in the new drug sector by stock performance were: - Lai Kai Medicine (42.26%) - Bei Hai Kang Cheng (25.00%) - Zai Ding Medicine (14.38%) - Ya Sheng Medicine (13.30%) - He Yu Biology (12.87%) - Conversely, the top five companies with the largest declines were: - WuXi AppTec (-16.06%) - Keji Pharmaceutical (-15.58%) - Sheng Nuo Medicine (-14.32%) - Yi Ming Ang Ke (-13.70%) - Teng Sheng Bo Medicine (-10.83%) [1][16]. New Drug Approval & Acceptance Status - This week, five new drugs or new indications were approved for market launch, 49 new drugs received IND approval, 56 new INDs were accepted, and 11 new NDAs were accepted [22][30]. - Notable approvals include: - Heng Rui Medicine's Camrelizumab combined with Rivoceranib for liver cancer received FDA acceptance [3][30]. - Rongchang Biopharmaceutical's new indication for Vidi Xi Tuo monoclonal antibody received acceptance from NMPA [3][30]. - Microchip Biopharmaceutical announced positive results for its Phase II clinical study of sodium siglitazone for non-alcoholic fatty liver disease [3][30]. Industry Performance - The biopharmaceutical sector has shown a relative return of 0.5% over the past month, with an absolute return of 24.2% [5]. - The sector has experienced a decline of 27% from October 2023 to February 2024, indicating volatility in the market [5]. Key Focus Areas in Domestic New Drug Industry - The report emphasizes ongoing developments in the domestic new drug industry, with several companies making significant progress in clinical trials and product approvals, including: - Heng Rui Medicine's multiple new cancer drugs receiving clinical trial approvals [30]. - Rongchang Biopharmaceutical's new indication for its monoclonal antibody [30]. - Microchip Biopharmaceutical's promising clinical results for its new drug [30].