政策动向 医疗器械上市后监管工作座谈会在天津召开 国家药监局12月26日在天津召开医疗器械上市后监管工作座谈会，总结监管成绩，分析形势，研究2026 年工作。会议强调，要深入贯彻党的二十大和二十届历次全会精神，按照国家药监局统一部署，统筹安 全与发展、秩序与活力等，精心谋划2026年重点工作。国家药监局相关司局、直属单位，部分省药监局 代表参加会议。在津期间，徐景和到医疗器械企业和天津大学脑机交互与人机共融海河实验室实地调 研，了解智能制造场景、国家集采和家用医疗器械监管、脑机交互技术研发创新等有关情况，要求企业 全面加强质量管理体系建设，确保高水平安全。 21点评：强化医疗器械上市后监管，既直击民生用械安全痛点，又贴合产业创新趋势，进一步为产业高 质量发展划定合规边界，实现监管效能与产业活力的良性平衡。 国家卫健委：目前所有省份实现医疗机构间检查检验结果互认项目超200项 12月26日，国家卫生健康委举行新闻发布会，介绍为民服务实事项目有关情况。目前，全国所有省份实 现地市内医疗机构之间检查检验结果互认项目超过200项。 药械审批 诺和诺德长效生长激素诺泽优®正式在华获批 12月26日消息，近日，国家药品监 ...

格隆汇12月16日丨一品红(300723.SZ)在投资者关系中表示，有被问到:公司对于AR882申报NDA有什么 样的时间计划？ 答:AR882在国内审批的时间大致为预计2026年年中左右临床结束，完成数据整理及报告后，将提交至 NDA，申报成功后NDA审批预计需要约12-15个月的时间，获批后将启动商业化，具体以项目实际情况 为准，公司将全力推动项目高效审批和快速上市销售。 ...

Policy Developments - The National Healthcare Security Administration exposed a healthcare fraud industry chain in Shanghai, leading to the prosecution of an individual for fraud, resulting in significant losses to the national healthcare fund [1] - The crackdown on healthcare fraud has become more systematic and normalized in recent years, highlighting the importance of protecting the healthcare fund [1] Drug and Device Approvals - Anglicon received a drug registration certificate for Ertugliflozin Metformin Extended-Release Tablets, aimed at improving blood sugar control in adults with type 2 diabetes [2] - Betta Pharmaceuticals announced that its application for the marketing authorization of Ensartinib Capsules for treating ALK-positive non-small cell lung cancer has been accepted by the European Medicines Agency [3] - Innovent Biologics received approval for its IL-23p19 monoclonal antibody for the treatment of moderate to severe plaque psoriasis in adults [4] - Warner Pharmaceuticals obtained a drug registration certificate for Formoterol Fumarate Inhalation Solution, intended for the maintenance treatment of COPD [5] - Shanghai Pharmaceuticals announced that its Tramadol Hydrochloride Injection passed the consistency evaluation for generic drugs, which may enhance its market competitiveness [6] Major Industry Events - Biontech received a milestone payment of $250 million from Bristol-Myers Squibb related to the Iza-bren project, with potential for additional payments based on future milestones [7] - Jining Pharmaceutical plans to invest 893 million yuan in a hospital expansion project to meet the growing health demands in the region [8] - Maiwei Biotech completed Phase IIa clinical trials for its innovative drug 9MW1911 in COPD patients, showing significant reductions in acute exacerbation rates [9] Shareholder Actions - Sanofi Biotech announced plans for shareholders to reduce their holdings by a total of 0.0240% of shares due to personal financial needs [10] Management Changes - Sinopharm Holdings announced management changes, including the resignation of several executives and the appointment of new leadership, which will take effect upon shareholder approval [11]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported R&D expenses of $10.3 million, an increase from $6.8 million in the same period last year, primarily due to expenses related to the DRAGON and Phoenix trials [5] - G&A expenses rose to $12.7 million from $2.9 million year-over-year, driven by increased share-based compensation expenses [5] - The net loss for Q3 2025 was $21.7 million, compared to a net loss of $8.7 million for the same period last year [5] - Total operating cash outflow for Q3 was approximately $9.3 million, similar to $8.6 million in Q2 [6] - At the end of Q3, the company had $275.6 million in cash and liquidity from time deposits and US Treasury bills [6] Business Line Data and Key Metrics Changes - The company completed enrollment for the phase 3 Phoenix trial with 530 subjects and the phase 3 DRAGON trial, with approximately 35 subjects enrolled out of a targeted 60 [3][4] - Positive feedback was received from regulatory authorities, including China's NMPA and the U.K.'s MHRA, regarding the DRAGON trial [4] Market Data and Key Metrics Changes - The company is preparing for submissions in multiple regions, including the U.S., Japan, and the U.K., with a focus on maintaining a consistent data package across regulatory agencies [8][14] - The company plans to submit applications in the first half of 2026 for regulatory approval in China and the U.K. [8] Company Strategy and Development Direction - The company is focused on advancing clinical trials and preparing for commercialization, with a strong balance sheet to support these efforts [6] - The U.S. market is prioritized for commercialization, with plans to apply for NDA in all regions, while seeking partnerships for other markets [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong foundation provided by the DRAGON trial for global submissions and potential approvals [4] - The company estimates that approximately $200 million will be needed for the commercialization of Saga in the U.S. [25] Other Important Information - The company completed a $50 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full bond exercise [4] - The increase in share-based compensation expenses was a significant factor in the overall expense increase [6] Q&A Session Summary Question: Has the application been submitted to regulatory agencies in China and the U.K.? - The company plans to submit applications in the first half of 2026 [8] Question: What is the current amount of shares outstanding? - The total outstanding shares are approximately 35 million [10] Question: When will the application be submitted in Japan? - The expected timeline for submission in Japan is also the first half of 2026 [14] Question: Will there be an interim analysis for the Phoenix trial similar to the DRAGON trial? - Yes, an interim analysis is planned for the second half of next year [16] Question: What should be assumed as the baseline level for SG&A expenses going forward? - It is difficult to estimate a clear baseline due to the variability related to share price and ESOP [18] Question: What steps are being taken to prepare for potential approval and launch? - The focus is on the U.S. market, with plans to start with a sales force of 20 to 40 people [23] Question: Is the current cash sufficient for commercial preparation and launch? - The company estimates that $200 million will be needed for commercialization, and believes current cash should be sufficient [25] Question: Did the U.K. request the same interim information as the U.S. FDA? - Yes, the same dataset was presented to both the U.K. and China [30]

Core Viewpoint - The company has shown consistent performance over the last 10 quarters, beating expectations but has become more cautious due to generic expiries impacting sales, particularly for its heart failure drug Inresto, while other drugs in its portfolio continue to perform well and drive future growth [1][2][4]. Financial Performance - The company reported a narrow beat in its latest quarter but did not raise its guidance, marking a shift in outlook due to the loss of exclusivity for Inresto [1][2]. - The full impact of Inresto's loss of exclusivity is expected to be felt in Q4, with continued strong performance from other growth drivers anticipated to support recovery [4]. Product Pipeline and Approvals - The company is optimistic about upcoming drug approvals, including Rapsido for chronic spontaneous urticaria, which could be a multi-billion dollar asset, and additional indications for its prostate cancer drug [6][7]. - Three significant approvals are expected next year, which are anticipated to drive future growth [8]. M&A Activity - The company recently completed a $12 billion acquisition of Aidity, aimed at enhancing its neuromuscular pipeline, which is seen as a strategic fit for long-term growth [8][9][11]. - This acquisition is part of a broader strategy, with over 35 deals made in the past year, focusing on scientific and technological alignment [12][13]. Regulatory Environment - The company is actively engaged in discussions with the White House regarding drug pricing and tariffs, aiming to find solutions that will not adversely affect profits [16][19]. - The administration's focus is on ensuring that international markets reward innovation appropriately, which could impact future product launches [20][21]. Investment in US Facilities - The company plans to invest $23 billion in US facilities, which is expected to help mitigate tariff impacts and support domestic production [23][24][25].

Core Viewpoint - The approval of the supplementary application for Progesterone cream by Beijing Jincheng Taier Pharmaceutical Co., Ltd. enhances product competitiveness but will not significantly impact current performance [1] Group 1: Regulatory Approval - Beijing Jincheng Taier Pharmaceutical Co., Ltd. received a notification from the National Medical Products Administration regarding the approval of a supplementary application for Progesterone cream [1] - The approval involves changes in the types and quantities of excipients, processes, and quality standards [1] Group 2: Market Data - According to IMS data, global sales of Progesterone formulations are projected to be $78.0961 million in 2022, $94.3352 million in 2023, and $104 million in 2024 [1] - The approval is expected to improve the product's competitiveness in the market [1]

Summary of GSK 2025 Conference Call Company Overview - **Company**: GSK (NYSE:GSK) - **Date**: September 24, 2025 - **Key Speakers**: Julie Brown (CFO), Tony Wood (Head of R&D) Core Industry Focus - GSK is focused on four major therapeutic areas: oncology, respiratory, immunology, and inflammation [2][3] - The company has upgraded its sales guidance to over $40 billion by 2031, up from $33 billion a few years ago [3][14] Financial Performance - GSK has had a strong year, achieving positive growth driven by its specialty business, particularly in oncology and respiratory sectors [2][3] - The company reported 13 phase III positive readouts last year, a record for GSK [3][4] - GSK is on track for five major approvals and four launches this year, including Blenrep and Depemokimab [3][4] Product Pipeline and R&D - **Oncology**: Blenrep is a key product, with significant expectations for growth. The company anticipates that half of the $6 billion gap in sales consensus is centered on Blenrep [15][16] - **Respiratory**: Depemokimab is expected to receive approval in December, with promising data showing a 72% reduction in exacerbations leading to hospitalization [26][27] - **HIV**: GSK's HIV business is performing well, with an upgrade in growth expectations from mid-single to high-single digits, driven by products like Cabenuva and Apretude [44] Regulatory Environment - GSK is actively engaging with the U.S. government regarding pricing policies, including the Most Favored Nation (MFN) proposal and its implications for drug pricing [6][8] - The company is preparing for negotiations regarding two products, Trelegy and Breo, with results expected in November [11] Market Dynamics - GSK is experiencing strong double-digit growth for Trelegy, despite industry challenges [11] - The company is optimistic about the long-term potential of its HIV portfolio, particularly with the upcoming Q6M product launch [44][46] Shingrix Performance - Shingrix has reached 42% market penetration in the U.S., with growth expected to come from international markets, particularly in Europe and China [62][63] Upcoming Data and Expectations - GSK is looking forward to significant data readouts in 2026, particularly for Camlipixant and Bepirovirsen, which are expected to drive future growth [64][75] - The company is confident in the potential of Bepirovirsen to provide a functional cure for chronic hepatitis B, with a focus on increasing diagnosis rates [75][76] Conclusion - GSK is positioned for strong growth with a robust pipeline and strategic focus on innovation and market expansion. The company is navigating regulatory challenges while maintaining a positive outlook on its product launches and market performance [3][14][44]

Core Viewpoint - Recently, the company’s subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical Factory, received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety information of several products [1] Group 1 - The approved products include Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules, which will improve the safety, effectiveness, and rational use of these drugs [1] - The approval is expected to enhance the market competitiveness of the products [1] - The approval will not have a significant impact on the company's current performance [1]

Core Viewpoint - China Resources Double Crane (600062.SH) announced that its wholly-owned subsidiary, Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd. (referred to as "Shanghai Changfu"), has received the approval notice for the supplementary application of peritoneal dialysis solution (lactate-G1.5%) and peritoneal dialysis solution (lactate-G2.5%) from the National Medical Products Administration (NMPA) [1] Group 1 - The peritoneal dialysis solution (lactate) is primarily used for patients with acute and chronic renal failure who require continuous non-bedside peritoneal dialysis treatment due to ineffective non-dialysis therapy [1] - The approval of the supplementary application for the peritoneal dialysis solution (lactate) represents an enhancement of the product specifications, which is expected to benefit the future market sales and competitive potential of this product series [1]

Core Viewpoint - China Resources Double Crane (600062.SH) announced that its wholly-owned subsidiary, Shanghai Changzheng Fumin Jinsan Pharmaceutical Co., Ltd. (referred to as "Shanghai Changfu"), received the Drug Supplement Application Approval Notice from the National Medical Products Administration for peritoneal dialysis solutions (lactate-G1.5% and lactate-G2.5%) [1] Group 1 - The peritoneal dialysis solutions (lactate) are primarily suitable for patients with acute and chronic renal failure who require continuous non-bedside peritoneal dialysis treatment due to ineffective non-dialysis therapy [1] - The approval of the Drug Supplement Application is a further enhancement of the specifications for the peritoneal dialysis solutions (lactate), which will benefit the future market sales and competitive potential of this product series [1]