Regulatory Approvals - Bristol Myers Squibb's Breyanzi received approval as the first CAR T-cell therapy for marginal zone lymphoma [1] - Gamida Cell Ltd.'s Omisirge became the first hematopoietic stem cell transplant therapy for severe aplastic anaemia [2] - Fondazione Telethon's Waskyra is noted as the first cell-based gene therapy for Wiskott-Aldrich syndrome and the first approved cell and gene therapy product from a non-profit applicant [2] Drug Approvals Overview - In 2025, a total of 44 novel drugs have received FDA approval, a decrease from 50 approvals in the previous year [3] - Anticipated regulatory decisions and approvals are expected in January 2026 [3]

Investment Rating - The report does not explicitly provide an investment rating for the biopharmaceutical sector [5]. Core Insights - The biopharmaceutical sector is experiencing significant activity with multiple companies focusing on innovative drug development, particularly in the area of siRNA targeting INHBE, which shows promise for fat reduction without muscle loss [3][24]. - The report highlights the recent performance of new drug stocks, with notable gains from companies such as Saint Nor Pharmaceutical (+30.88%) and Dongyao Pharmaceutical (+16.37%), while companies like Kexin Pharmaceutical (-14.19%) and Rongchang Biotechnology (-10.09%) faced declines [1][15]. - There is an expectation of multiple catalysts in the sector, including academic conferences and data releases, which could drive further interest and investment [2]. Weekly New Drug Market Review - From December 8 to December 14, 2025, the new drug sector saw significant stock movements, with the top five gainers and losers listed [1][15]. - The report notes that there were no new drug approvals during this week, but 11 new drug applications were accepted [4][31]. Weekly New Drug Industry Analysis - Wave Life Sciences has reported promising initial data for its siRNA drug WVE-007, which targets INHBE and demonstrates potential for reducing visceral fat while preserving muscle mass [3][24]. - The report indicates that several companies, both globally and domestically, are actively developing siRNA drugs targeting INHBE, with five drugs already in clinical development [27][28]. Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but 11 new drug applications were accepted [4][31]. - A total of 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted during the week [9][34]. Key Events in Domestic Market - Significant events include the approval of new drugs by companies such as Zhengda Tianqing and Nuo Cheng Jian Hua, which received approval for their respective new drugs [10][11]. Key Events in Overseas Market - Noteworthy overseas events include Eli Lilly's announcement of positive results from its TRIUMPH-4 Phase 3 trial and the FDA's approval of a gene therapy by Fondazione Telethon [11].