Core Viewpoint - BeiGene (6160.HK) announced that its self-developed first-in-class BCL2 inhibitor, Baiyueda® (Sotukral tablets), has received conditional approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic treatments including a BTK inhibitor [1] Group 1 - The approval of Sotukral provides a new treatment option for CLL/SLL patients who have previously been treated with BTK inhibitors [1] - Sotukral becomes the first and only BCL2 inhibitor approved for the treatment of MCL in China [1] - The applications for these indications were previously included in the priority review process by the NMPA's Center for Drug Evaluation (CDE) [1]

Core Viewpoint - BeiGene announced that its self-developed first-in-class BCL2 inhibitor, Baiyueda® (Sotoclisib), has received conditional approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies including a BTK inhibitor [1] Group 1 - The approval of Sotoclisib provides a new treatment option for CLL/SLL patients who have previously been treated with BTK inhibitors [1] - Sotoclisib becomes the first and only BCL2 inhibitor approved for the treatment of MCL in China [1] - The applications for these indications were previously included in the priority review process by the NMPA's Center for Drug Evaluation (CDE) [1]

Group 1 - The core point of the article highlights that in December 2025, the worst-performing ordinary equity and mixed funds were both managed by Baoying Fund, specifically the Baoying Medical Health Hong Kong-Shenzhen Stock A and C, which reported returns of -13.20% and -13.26% respectively [1] - The Baoying Innovation Medical Mixed Initiation A and C funds also performed poorly, with returns of -14.14% and -14.19%, making them the worst in the mixed fund category [1] - All these funds are themed around the medical sector and are managed by the same fund manager, Yao Yi, who has a background in research and fund management [1] Group 2 - The latest quarterly report indicates that the top ten holdings of the Baoying Medical Health Hong Kong-Shenzhen Stock fund include major companies such as Innovent Biologics, Kelun Pharmaceutical, and others, while the Baoying Innovation Medical Mixed Initiation fund shares many of the same top holdings [1][2] - Notably, several of these top holdings experienced significant declines in December, with the largest holding, Innovent Biologics, dropping by 18.97%, and another major holding, 3SBio, declining by over 22% [2] - The performance metrics of the funds show that the Baoying Innovation Medical Mixed Initiation C has a cumulative net value of 0.8857 and a scale of 0.51 billion, while the A share has a cumulative net value of 0.8886 and a scale of 0.47 billion [3]

Summary of BeOne Medicines Conference Call Company Overview - **Company**: BeOne Medicines (ONC/688235.SS) - **Industry**: Oncology, specifically focused on hematology and solid tumors - **Key Products**: Sonrotoclax (BCL2 inhibitor), Brukinsa, Tevimbra - **Location**: Domiciled in Switzerland Key Points from the Conference Call Approval and Market Entry - **Sonrotoclax Approval**: Approved in China for late-line Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) on January 5th, 2025, marking its first approval globally [1] - **NDA Review Duration**: The approval process took only eight months, which is considered quick compared to the typical 12-18 months for new drug approvals [1] - **Unmet Need**: The rapid approval reflects a significant unmet need for BCL2 inhibitors in China, as venetoclax was only approved for Acute Myeloid Leukemia (AML) [1] Market Dynamics and Sales Potential - **Sales Ramp-Up**: Interest in tracking the sales ramp-up of venetoclax and lisaftoclax, along with feedback from physicians and patients regarding the new BCL2 inhibitors [2] - **Differentiation Factors**: - **Tolerability**: Both new drugs showed lower rates of neutropenia and discontinuation compared to venetoclax, with sonrotoclax showing a lower rate than lisaftoclax [2] - **Dose Ramp-Up**: Lisaftoclax employs a 4-6 days daily dose ramp-up, while sonrotoclax and venetoclax use a weekly ramp-up [2] Financial Projections and Valuation - **Earnings Adjustment**: FY2025-2027 earnings per share (EPS) estimates adjusted from US$3.78/US$6.26/US$6.64 to US$3.59/US$4.65/US$4.46 [6] - **Increased Probability of Success (POS)**: Blended POS increased from 76% to 95% due to the approval of sonrotoclax [6] - **Target Prices**: Updated 12-month target prices to US$385.79 for ONC and Rmb345.86 for A-share, down from US$408.79 and Rmb366.48 respectively [6] Company Positioning and Risks - **Growth Potential**: BeOne Medicines is well-positioned for growth with a strong internal clinical development team and a focus on oncology [7] - **Key Risks**: - Uncertainties in R&D and regulatory approvals, especially for early-stage solid tumor products - Competition from BTK and PD-1 inhibitors - Development risks for clinical-stage assets - Market access bottlenecks [7][10] Conclusion - **Investment Rating**: Maintained a Buy rating on BeOne Medicines, indicating confidence in its growth potential and market positioning despite broader macroeconomic concerns [7]

Summary of Key Points from the Conference Call Industry Overview - The pharmaceutical sector is currently in a left-side layout phase after adjustments in 2025, with both institutional holdings and valuations positioned for upward elasticity, particularly in innovative drugs and their supply chains for 2026, benefiting from China's strengthening innovation competitiveness [1][4] - The recovery of the innovative industry chain is expected to continue, with CDMO orders and performance starting to recover from 2024, further improving in 2025 and expected to sustain into 2026 [1][9] Core Insights and Arguments - The driving forces behind the enhancement of China's innovation competitiveness include the successful implementation of business development (BD), overseas clinical progress, and commercialization, along with breakthroughs in new technologies such as XDC, dual antibodies, and small nucleic acids [5] - Investment opportunities in 2026 are concentrated in globally competitive assets, including innovative drugs, high-end manufacturing, and domestic demand-related sectors, particularly those with recovery logic [2] - The domestic demand recovery trend is clear, strengthening quarter by quarter in 2025, driven by high domestic innovation BD, a warming primary and secondary market, and an increase in IPOs in both A-shares and Hong Kong stocks [20] Notable Companies and Technologies - Key companies to watch include Innovent Biologics, Botai Biological Products, and Engen Biologics, which are core recommended assets due to their potential for significant data readouts and BD catalysts [6][10] - In the CRO sector, companies like Tigermed and Zhaoyan New Drug are expected to see performance turning points in 2026, supported by a recovery in domestic demand [3][21] - The CDMO sector is projected to continue its growth trajectory, with leading companies such as WuXi AppTec and Kelun Biotech expected to perform well due to increasing orders from overseas [22][23] Emerging Technologies and Investment Opportunities - Emerging technologies such as brain-computer interfaces and AI in pharmaceuticals are anticipated to bring new investment opportunities, with potential IPOs in these areas [12][29] - The central OTC sector is expected to see marginal recovery in 2026, with key companies like China Resources and Dong'e Ejiao being highlighted for their potential growth [13][30] Upcoming Catalysts and Key Events - Important upcoming events include the JPMorgan conference, which may provide data updates and BD changes, and significant data readouts expected in Q1 and April from major conferences [8][10] - The performance of companies in the first quarter of 2026 is anticipated to show significant elasticity and fundamental support, particularly in the CRO and innovative drug sectors [11][20] Conclusion - The pharmaceutical industry is positioned for a recovery phase with significant investment opportunities in innovative drugs, CDMO, and CRO sectors, driven by domestic demand recovery and technological advancements. Key companies and upcoming events will play a crucial role in shaping the market dynamics in 2026 [1][2][4][20]

医疗健康（980016）指数十大成份股详情如下： 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 证券之星消息，1月5日，医疗健康（980016）指数报收于6299.52点，涨3.48%，成交383.49亿元，换手 率1.16%。当日该指数成份股中，上涨的有47家，百济神州以12.02%的涨幅领涨，下跌的有3家，常山 药业以1.0%的跌幅领跌。 资金流向方面，医疗健康（980016）指数成份股当日主力资金净流入合计9.47亿元，游资资金净流出合 计11.15亿元，散户资金净流入合计1.68亿元。成份股资金流向详情见下表： ...

Core Viewpoint - The biopharmaceutical industry in China experienced a volatile year in 2025, with significant growth in the first half followed by a sharp decline in the latter half, indicating a restructuring of the underlying logic of the industry [1][2][28]. Group 1: Industry Performance - The innovative drug sector saw explosive growth in the first half of 2025, with the China Innovation Drug Index rising by 13.43% and the Hong Kong Innovation Drug Index increasing by 60% [1][27]. - By December 28, 2025, the Hong Kong Innovation Drug Index had dropped over 20% since September, with many unprofitable biotech companies experiencing declines of over 40% [1][27]. Group 2: Policy Support - In 2025, the policy environment for biopharmaceuticals in China evolved to integrate national and local support, creating a comprehensive system for innovative drug development [4][30]. - Key policy initiatives included the release of measures to support innovative drug development, focusing on research support, inclusion in insurance, and clinical application [4][30]. - The introduction of a 30-day expedited review process for innovative drug clinical trial applications was implemented to enhance efficiency [4][30]. Group 3: Technological Advancements - The integration of AI in drug development accelerated in 2025, with AI tools becoming standard in pharmaceutical research and development [14][39]. - AI-driven companies like Insilico Medicine achieved significant milestones, including the rapid progression of drug candidates through clinical trials [14][40]. Group 4: Payment System Changes - The payment landscape for innovative drugs shifted from a focus on the lowest price to a more balanced approach that considers quality and reasonable pricing [16][42]. - The introduction of a commercial health insurance directory for innovative drugs marked a significant development, allowing for better access and affordability for patients [19][45]. Group 5: Business Development Transactions - The business development (BD) landscape in the innovative drug sector transitioned from a phase of enthusiasm to a more rational evaluation of value [22][48]. - By the end of 2025, the total amount of overseas licensing agreements in China's innovative drug sector exceeded $130 billion, setting a historical record [50]. - However, market reactions to BD announcements became more subdued, with significant stock price declines following major deals, indicating a reassessment of the quality and sustainability of such transactions [50][51].

药物临床试验登记与信息公示平台数据显示，广州百济神州生物制药有限公司的一项探索靶向 EGFR×MET 的抗体偶联药物 BG - C0902 单药治疗和与其他治疗药物联合用药治疗晚期实体瘤患者的安 全性、耐受性、药代动力学、药效学和初步抗肿瘤活性的1a/1b 期研究已启动。临床试验登记号为 CTR20255132，首次公示信息日期为 2026 年 1 月 5 日。 该药物剂型、用法用量暂未公示。本次试验主要目的为评价 BG - C0902 治疗晚期实体瘤患者的安全 性、耐受性、PK、药效学和初步抗肿瘤活性，研究分 2 个阶段进行：1a 期（剂量递增和安全性扩展） 和 1b 期（剂量扩展）。 责任编辑：小浪快报 （ORR）；1a 期和 1b 期缓解持续时间（DOR）和疾病控制率（DCR）；1b 期基于研究者使用 RECIST 1.1 版进行的肿瘤评估确定的无进展生存期（PFS）；1b 期发生不良事件和严重不良事件的患者数量； 1a 期和 1b 期 BG - C0902、总抗体和有效载荷 BGB - 40410 在规定时间点的浓度和其他 PK 参数；1a 期 和 1b 期通过检测抗药抗体（ADA）评价 BG - C ...

Group 1 - The chemical pharmaceutical sector increased by 3.63% on January 5, with Frontier Biotech leading the gains [1] - The Shanghai Composite Index closed at 4023.42, up 1.38%, while the Shenzhen Component Index closed at 13828.63, up 2.24% [1] - Notable stock performances included Frontier Biotech with a closing price of 21.20, up 17.45%, and Beilu Pharmaceutical at 66.8, up 13.22% [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 716 million yuan from institutional investors, while retail investors contributed a net inflow of 131 million yuan [2] - Major stocks with significant net inflows included Heng Rui Pharmaceutical with 17.4 million yuan and ST Renfu with 9.15 million yuan [3] - Conversely, stocks like ST Jinfeng and Kangzhiyue experienced net outflows of 6.90 million yuan and 11.61 million yuan respectively [2][3]

Market Overview - The Shanghai Composite Index closed at 4023.42 points, above the six-month moving average, with an increase of 1.38% [1] - The total trading volume of A-shares reached 30,483.30 billion yuan [1] Stocks Above Six-Month Moving Average - A total of 313 A-shares have surpassed the six-month moving average today [1] - Notable stocks with significant deviation rates include: - BeiYikang (证券代: 920199) with a deviation rate of 19.09% and a price increase of 29.98% [1] - *ST Huike (证券代: 300561) with a deviation rate of 18.68% and a price increase of 19.99% [1] - Weisi Medical (证券代: 688580) with a deviation rate of 18.24% and a price increase of 20.00% [1] Stocks with Smaller Deviation Rates - Stocks with smaller deviation rates that have just crossed the six-month moving average include: - Garden Holdings (证券代: 300430) with a deviation rate of 13.12% and a price increase of 19.98% [1] - Hongya CNC (证券代: 301033) with a deviation rate of 13.22% and a price increase of 20.00% [1] - Zhongke Sanhuan (证券代: 688314) with a deviation rate of 12.97% and a price increase of 19.99% [1]