新京报讯（记者张秀兰）6月9日，国家药监局发布的药品批准证明文件送达信息显示，强生旗下古塞奇 尤单抗注射液（静脉输注）（特诺雅达）在华上市，用于治疗对传统治疗或生物制剂应答不充分、失应 答或不耐受的中度至重度活动性克罗恩病和溃疡性结肠炎的成人患者。 校对 贾宁 作为首个也是唯一的全人源、具有双重作用机制、可选择性中和白介素23的抑制剂，特诺雅达和特诺雅 （古塞奇尤单抗注射液）在克罗恩病和溃疡性结肠炎的治疗中均能提供持续的深度缓解。双盲头对头注 册临床试验显示，古塞奇尤单抗展现了针对克罗恩病治疗在多重控制的内镜终点上对比喜达诺（乌司奴 单抗）的优效性。研究显示，在一年内有45%-50%的溃疡性结肠炎患者达到了临床缓解，34%-35%的患 者实现了内镜缓解。 过去几十年间，克罗恩病（CD）和溃疡性结肠炎（UC）在中国的发病率持续上升，作为常见的炎症性 肠病（IBD），其发病高峰年龄呈现提前趋势。其中，克罗恩病是一种可累及全消化道的透壁性、慢性 炎性肉芽肿性疾病，至今尚无明确病因，但该疾病与免疫系统的异常有关，可能由遗传易感性、饮食或 其他环境因素引发。克罗恩病的症状可能有所不同，但通常包括腹痛、腹泻、瘘管形成、体 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Viewpoints - The GLP-1 weight loss drugs are experiencing explosive growth globally and in China, with significant sales figures expected for the year [7] - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index [5][15] - The industry PE (TTM) as of May 9, 2025, is 26.77x, showing an upward trend but still below the average [20] Industry Review - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index which increased by 1.56% [5][15] - The medical equipment and pharmaceutical distribution sectors showed the highest gains, with increases of 3.92% and 2.38% respectively, while medical research outsourcing saw a decline of 0.65% [5][15] - As of May 9, 2025, the PE (TTM) for the pharmaceutical and biotechnology industry is 26.77x, up from 26.34x in the previous period, indicating a valuation increase [20] Investment Suggestions - The current trend in GLP-1 weight loss drugs indicates a golden development period for the industry, with significant sales growth expected both globally and in China [7] - The report suggests focusing on companies with solid clinical data, sufficient production capacity, and integrated supply chain capabilities [7] Important Industry News - The NMPA has released new regulations for the quality management of online sales of medical devices, effective from October 1, 2025 [25] - The approval of the first long-acting analgesic new drug in China, "Meloxicam Injection," marks a significant milestone in the industry [31] - Johnson & Johnson's "Guselkumab Injection" has been approved as the first IL-23 inhibitor for treating ulcerative colitis in China [33] - The investment of 2.04 billion RMB by Roche in a new biopharmaceutical production base in Shanghai highlights the ongoing commitment to local production and supply chain enhancement [43]

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 集采政策新动向：优化方案流出 近日，《进一步优化药品集采政策的方案（征求意见稿）》（以下简称《征求意见稿》）在业内流传， 引发广泛关注。 据业内流传的信息，这已是《征求意见稿》的第二稿。今年政府工作报告中明确指出，"优化药品和耗 材集采政策，强化质量评估和监管，让人民群众用药更放心。"3月26日，关于开展优化医药集采工作的 研讨在北京召开，北京、天津、上海等地的医保负责人参与会议。随后，《征求意见稿》第一稿流出。 相比于第一稿内容，第二稿强调了医用耗材的集采，并非仅仅提及药品集采。同时整合了多处内容，删 除了一些细节规定，政策灵活性更强。 21点评：近些年，药品集中采购正被快速推进。自2018年"4+7"带量采购以来，国家先后组织10批药品 集采和5批高值医用耗材集采，累计成功采购435种药品。在这一过程中，集采政策被持续优化。 5月9日，驯鹿生物称沙特阿拉伯王国食品药品监督管理局（Saudi Food and Drug Authority, SFDA）授予 其自主研发的靶向BCMA的CAR-T细胞治疗产品 ...