新药周观点:医保谈判即将启动,约41个国产创新药有望新增药品谈判
Guotou Securities·2024-10-13 12:28

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [5]. Core Insights - The upcoming medical insurance negotiations are expected to include approximately 41 domestic innovative drugs, which have passed the preliminary review, potentially expanding the drug list for negotiations [2][12]. - The new drug market has shown significant fluctuations, with notable increases in stock prices for companies like Jiahe Biopharma (11.52%) and Hualing Pharmaceutical (5.00%), while companies like Beihai Kangcheng experienced a sharp decline (-37.00%) [1][9]. Summary by Sections 1. Weekly New Drug Market Review - From October 7 to October 11, 2024, the top five companies in the new drug sector by stock price increase were Jiahe Biopharma (11.52%), Hualing Pharmaceutical (5.00%), and Boan Biopharma (3.00). The top five companies with the largest declines included Beihai Kangcheng (-37.00%) and Shengnuo Pharmaceutical (-21.00%) [1][9]. 2. Key Analysis of the New Drug Industry - The National Healthcare Security Administration has outlined the process for the 2024 National Drug List adjustment, which includes preparation, application, expert review, negotiation/bidding, and result announcement phases. The negotiation phase is about to commence, with 41 domestic exclusive innovative drugs expected to participate [2][12]. - Among these, 28 innovative drugs approved between July 1, 2023, and June 30, 2024, and 13 drugs approved before July 1, 2023, are anticipated to be included in the negotiations [12][22]. 3. New Drug Approval and Acceptance Status - In the past week, 9 new drugs or new indications were approved for market entry, 58 new drugs received IND approvals, 51 new drugs had IND applications accepted, and 21 new drugs had NDA applications accepted [18][20]. - Notable approvals include Heng Rui Medicine's injectable paclitaxel, which became the first generic drug of its kind approved in the U.S. [3][18]. 4. Focus on Domestic New Drug Industry - The report highlights the approval of several innovative drugs, including those targeting various cancers and chronic conditions, indicating a robust pipeline in the domestic biopharmaceutical sector [12][22]. 5. Focus on Overseas New Drug Industry - Key overseas developments include the FDA's approval of Roche's oral small molecule therapy for breast cancer and Pfizer's positive results from a Phase 3 trial of a PARP inhibitor [3][18].