Core Viewpoint - The introduction of a dual-track payment system for innovative drugs in China, combining basic medical insurance and commercial health insurance, marks a significant shift in the industry, providing a structured approach to address the payment challenges faced by high-priced innovative drugs [2][5][34]. Summary by Sections Introduction - The release of the new medical insurance directory and the first commercial health insurance directory for innovative drugs signifies the establishment of a dual-track payment system in China [2]. Innovative Drug Payment Mechanism - The reliance on a single payment channel through medical insurance has become unsustainable due to rising costs and the increasing number of high-priced innovative drugs [5]. - The latest medical insurance directory adds 114 new drugs, with 50 being class 1 innovative drugs, achieving a negotiation success rate of 88%, the highest ever [5]. Commercial Health Insurance Directory - The first commercial health insurance directory includes 19 high-value innovative drugs, providing a structured payment pathway for drugs previously excluded from medical insurance [8][20]. - This directory signals a shift in the payment structure, where both basic medical insurance and commercial insurance will share the payment responsibilities for innovative drugs [8][21]. Challenges in Medical Insurance - Despite the expansion of the medical insurance directory, high-priced innovative drugs still face significant barriers to entry due to strict cost-effectiveness evaluations and negotiation mechanisms [10][11]. - The trend indicates that medical insurance is moving towards risk control rather than merely expanding coverage [10][16]. Filling the Payment Gap - The introduction of the commercial health insurance directory is a necessary response to the limitations of the medical insurance system, providing a payment avenue for high-value drugs that have been excluded [18][21]. - The directory includes drugs with high clinical value and costs, addressing the long-standing payment vacuum in the market [18][20]. Growth Opportunities for Innovative Drugs - The commercial health insurance directory opens new growth avenues for high-priced innovative drugs, allowing for a broader patient reach and a more structured payment approach [23][24]. - The directory is expected to enhance the commercial health insurance market, with high-value innovative drugs becoming a core differentiator in product offerings [24]. Structural Bottlenecks for Commercial Health Insurance - There are significant barriers to the short-term adoption of the commercial health insurance directory, including data insufficiency, product risk acceptance, and user payment behavior [28][29][30]. - The lack of real-world data on innovative drug usage complicates pricing and risk assessment for insurance companies [29]. Conclusion - The dual-track payment system represents a structural change in the payment landscape for innovative drugs, but challenges remain in achieving widespread accessibility and effective implementation [34][35]. - The commercial health insurance system is expected to play an increasingly important role in providing payment solutions for innovative drugs, although it will take time to fully realize its potential [36].

12月12日午后，港股通创新药板块回暖，高弹性港股通创新药ETF（520880）翻红后持续拉升，现涨超 1%，今日有望终结日线4连阴形态。值得关注的是，本周520880迎来"抄底"资金增仓，累计净申购额超 1.3亿元。 成份股方面，权重龙头股康方生物领涨逾6.8%，信达生物涨超2%，百济神州涨逾1%。云顶新耀、同源 康医药-B、映恩生物-B等涨幅居前。 据康方生物官微消息，其全球首创的PD-1/CTLA-4双特异性抗体卡度尼利单抗联合化疗，对比化疗联 合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃或胃食管结合部腺癌一线 治疗的国际多中心Ⅲ期临床研究(COMPASSION-37/AK104-311)，已获得美国食品药品监督管理局 (FDA)批准开展。 平安证券研报提示，从BD、商业化、政策三个角度看，创新药崛起具备持续性，建议关注：1）管线布 局丰富的创新药公司；2）创新药单品潜力大，价格有望重估的企业；3）看好前沿技术平台布局领先的 企业。 1、纯粹，全面。不含CXO，纯正创新药！全面覆盖创新药研发类公司。 2、龙头占比大。前十大创新药龙头权重超72%，表征创新药硬核力量。 3、风险更 ...

12月12日午后，港股通创新药板块回暖，高弹性港股通创新药ETF（520880）翻红后持续拉升，现涨超 1%，今日有望终结日线4连阴形态。值得关注的是，本周520880迎来"抄底"资金增仓，累计净申购额超 1.3亿元。 | 分时 多日 1分 5分 * | | | | F9 盘前盘后 图加 九50 图线 工具 @ (2 > | | | | | 港股通创新药ETF ① | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 0.54 | | | 520880[種設通创新的ETF] 14:29 价 0.544 滚球 0.006(1.12%) | | | | 0.544 +0.006 +1.12% | | | 520880 | | 0.543 | | | | | DATES | | SSE CNY 14:29:30 交易中 查看L2全国 | | | 40 8 7 8 | | | | | | | | 净值击势 | 华宜恒生港胶通创新的用 | | 69.80 | | | 0.54 | | | | | 0.45 | 1248 | - ...

智通财经获悉，康方生物(09926)再涨超3%，截至发稿，涨3.83%，报121.9港元，成交额2.71亿港元。 消息面上，据康方生物官微消息，近日，公司宣布，全球首创的PD-1/CTLA-4双特异性抗体卡度尼利单 抗联合化疗，对比化疗联合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃 或胃食管结合部腺癌一线治疗的国际多中心Ⅲ期临床研究(COMPASSION-37/AK104-311)，已获得美国 食品药品监督管理局(FDA)批准开展。 据悉，COMPASSION-37研究是卡度尼利第二个国际多中心注册性临床研究。此前，卡度尼利方案治疗 免疫耐药肝细胞癌的国际注册性临床研究已经在美国开展。COMPASSION-37研究的开展是卡度尼利的 全球化开发向前再迈出的关键性一步，也是康方生物全球化战略的重要举措，将有力巩固公司在肿瘤免 疫2.0 领域的国际领先地位。 本文源自：智通财经网 ...

Core Viewpoint - 康方生物's stock has increased by over 3%, currently trading at 121.9 HKD with a transaction volume of 271 million HKD, following the announcement of FDA approval for its innovative PD-1/CTLA-4 bispecific antibody, 卡度尼利单抗, for a pivotal clinical trial [1] Group 1: Company Developments - 康方生物 announced the initiation of the COMPASSION-37/AK104-311 international multicenter phase III clinical study, which evaluates 卡度尼利单抗 in combination with chemotherapy for HER2-negative, untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [1] - This study represents the second international multicenter registration clinical trial for 卡度尼利, following a previous study focused on immune-resistant hepatocellular carcinoma that has already commenced in the United States [1] - The launch of the COMPASSION-37 study is a significant step forward in the global development of 卡度尼利 and is a key initiative in 康方生物's globalization strategy, reinforcing its leading position in the field of tumor immunotherapy 2.0 [1]

Core Viewpoint - 康方生物's stock has increased by over 3%, currently trading at 121.9 HKD with a transaction volume of 271 million HKD, following the announcement of FDA approval for its innovative PD-1/CTLA-4 bispecific antibody,卡度尼利单抗, for a pivotal clinical trial [1] Group 1 - 康方生物 announced the FDA approval for the international multicenter phase III clinical study (COMPASSION-37/AK104-311) of 卡度尼利单抗 in combination with chemotherapy for HER2-negative, untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [1] - The COMPASSION-37 study is the second international multicenter registration clinical study for 卡度尼利单抗, following a previous study for immune-resistant hepatocellular carcinoma [1] - The initiation of the COMPASSION-37 study marks a significant step forward in the global development of 卡度尼利单抗 and is a key initiative in 康方生物's globalization strategy, reinforcing its leading position in the tumor immunotherapy 2.0 field [1]

Core Insights - The pharmaceutical and biotechnology index experienced a decline of 0.64% during the week, underperforming the Shanghai Composite Index by 1.34 percentage points, ending a two-week upward trend [4] - The National Healthcare Security Administration released the 2025 National Basic Medical Insurance Drug List, which included 114 products, achieving a success rate of 88% in negotiations, the highest in recent years [5] - The launch of the commercial health insurance innovative drug list included 19 drugs, complementing the basic medical insurance list and indicating a shift towards a multi-tiered healthcare system in China [5][19] Weekly Market Performance - The A-share market saw significant gains for Haiwang Bio, which rose by 71.20%, while Zhongsheng Pharmaceutical increased by 15.56% [2] - In the Hong Kong market, Jinxin Reproductive Medicine and Boan Biotechnology saw increases of 7.53% and 8.62%, respectively [2] Clinical Trials and Innovations - Kangfang Biopharma's dual-antibody drug, Kadunilumab, has initiated a Phase II clinical trial for esophageal squamous cell carcinoma, a prevalent cancer type in China [13][14] - A clinical trial for a gout treatment, polyethylene glycol-uricase injection (HZBio1), has also commenced, targeting patients with poorly controlled uric acid levels [17][18] New Drug Developments - Baoyi Pharmaceutical's stock surged nearly 140% on its first trading day, with a market capitalization of HKD 20.5 billion, despite a significant net loss of CNY 183 million in the first half of 2025 [6][7] - The company has 12 self-developed products, with SJ02 being the first long-acting FSH-CTP product approved in China [7] Industry Trends - The trend of "innovation + internationalization" remains a core direction for the pharmaceutical sector, supported by policies and increasing global competitiveness [5] - The demand for more effective and safer uric acid-lowering drugs is rising due to the increasing prevalence of gout, particularly among younger populations in China [18]

Michael MENG Daily Spotlight 8 December 2025 (852) 3988 6433 michael.meng@bocigroup.com Index Performance | | Last close | % 1D | % YTD | | --- | --- | --- | --- | | HSI | 26,085 | 0.6 | 30.0 | | HSCEI | 9,198 | 1.0 | 26.2 | | HSCCI | 4,260 | 0.2 | 12.7 | | MSCI HK | 13,724 | (0.4) | 29.9 | | MSCI CHINA | 85 | 0.8 | 31.6 | | FTSE CHINA A50 | 15,237 | 0.6 | 12.8 | | CSI 300 | 4,585 | 0.8 | 16.5 | | TWSE | 27,981 | 0.7 | 21.5 | | SENSEX | 85,265 | 0.2 | 9.1 | | NIKKEI 225 | 50,492 | (1.1) | 26.6 | | KOSPI | 4 ...

Investment Rating - The report recommends an "Outperform" rating for leading pharmaceutical and biotech companies with robust pipelines, as well as high-quality CXOs and internet healthcare firms [1]. Core Insights - The report highlights the strong performance of innovative drug leaders such as BeiGene and Innovent Biologics, which have shown significant revenue growth in Q3 2025, with BeiGene achieving USD 1.41 billion in revenue (up 41% year-on-year) and Innovent exceeding CNY 3.3 billion (up 40% year-on-year) [39][40]. - The CXO sector experienced a pullback in November, with notable declines in stocks like WuXi AppTec and Tigermed, attributed to profit-taking after strong performance in the first three quarters of 2025 and concerns over geopolitical risks [42]. - The report emphasizes the importance of upcoming clinical data readouts from major conferences such as ESMO Asia and ASH, which could serve as catalysts for stock performance [10]. Summary by Sections Top Picks - The report lists top picks including Hansoh Pharma, 3SBio, Kelun-Biotech, Innovent, Akeso, JD Health, and WuXi AppTec, all rated as "Outperform" [1][4][35]. Performance Overview - The Hong Kong stock picks portfolio gained an average of 5.2% in November 2025, outperforming the Hang Seng Healthcare Index, which declined by 0.1% [5][36]. - The top three performers in the portfolio were Hansoh Pharma (+12.9%), BeiGene (+10.2%), and Innovent (+10.0%) [5][36]. Market Trends - The innovative drug sector has shown resilience, benefiting from previous corrections and strong earnings catalysts from leading companies [39]. - The report notes that the recent implementation of key industry policies, including the 11th National Centralized Drug Procurement, has led to significant price reductions for selected products, impacting market dynamics [38]. Clinical Developments - Significant clinical progress is noted for companies like 3SBio, which is advancing its SSGJ707 (PD-1/VEGF) with Pfizer, planning to initiate multiple clinical trials [41]. - The report also highlights the potential of innovative therapies in oncology, with companies like BeiGene and Innovent expanding their product pipelines and market presence [32][40].

Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The innovative drug sector is experiencing rapid growth, with several new drugs being quickly incorporated into the medical insurance directory as of October 2025 [3][20] - The report highlights significant increases in the number of drugs entering hospitals, particularly those newly included in the insurance directory, indicating strong market demand [3][19] Weekly New Drug Market Review - From November 24 to November 30, 2025, the top five performing new drug companies were: Frontline Bio (+23.12%), Yifang Bio (+15.74%), Rongchang Bio (+15.39%), Kangfang Bio (+14.86%), and Jakes (+14.18%). The five companies with the largest declines were: Yongtai Bio (-4.11%), Nothland (-3.33%), Junshengtai (-2.78%), Boan Bio (-2.09%), and Dongyao Pharma (-1.11%) [1][14] Suggested Focus Stocks - The report suggests focusing on several companies with promising catalysts, including: 1. Companies with MNC certification and high overseas sales potential: Sanofi, Lianbang Pharma, and Kelun Biotech 2. Companies with overseas data catalysts: Betta Pharma, Hutchison China MediTech, and Yimeng Bio 3. Potential heavyweights for overseas MNC licensing: Fuhong Hanlin, Shiyao Group, and Yifang Bio 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18] New Drug Industry Key Analysis - The National Healthcare Security Administration updated the data on innovative drugs included in the insurance directory as of October 2025, showing rapid hospital entry for several newly included domestic innovative drugs. Notable drugs with fast entry rates include: - Hengrui Medicine's Tazobactam - Innovent Biologics' Toripalimab - Haisco's Alogliptin and Clopidogrel - Sinopharm's Aliskiren and Amlodipine - Shanghai Yizhong's Paclitaxel polymer micelles - Kangfang Bio's Ivoris monoclonal antibody [3][19] New Drug Approval and Acceptance Status - This week, 11 new drugs or new indications received approval for market entry, while 13 new drugs or new indications were accepted for review [4][24] New Drug Clinical Application Approval and Acceptance Status - This week, 54 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [8][27]