Core Viewpoint - The approval of the new indication for the reversible Bruton's tyrosine kinase (BTK) inhibitor, Pirtobrutinib, represents a significant advancement in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously undergone systemic therapy including BTK inhibitors [1][2] Group 1: Product Approval and Mechanism - Pirtobrutinib has received approval from the National Medical Products Administration (NMPA) in China for use in adult CLL/SLL patients who have previously been treated with at least one systemic therapy including BTK inhibitors [1] - Pirtobrutinib is a highly selective kinase inhibitor that employs a novel binding mechanism, allowing it to restore BTK inhibition in patients previously treated with covalent BTK inhibitors [1] Group 2: Clinical Study Results - The approval is based on the results of the international multicenter, randomized controlled BRUIN CLL-321 Phase III study, which included 238 patients [2] - The study demonstrated that Pirtobrutinib significantly extended the median progression-free survival (PFS) to 14.0 months compared to 8.7 months for the control group, with a hazard ratio (HR) of 0.54 [2] - The treatment-related discontinuation rate for Pirtobrutinib was lower at 5.2% compared to 21.1% for the control group, confirming its efficacy and tolerability advantages in the population previously treated with covalent BTK inhibitors [2] Group 3: Market Impact and Future Plans - The approval of Pirtobrutinib for CLL/SLL in China marks a major breakthrough, allowing local patients to benefit from this global innovation [2] - The company aims to leverage its leading brand and expertise in oncology to accelerate the accessibility of this innovative therapy for more patients in need [2]

Core Viewpoint - The approval of the non-covalent BTK inhibitor, Pirtobrutinib (捷帕力®), for a new indication in China represents a significant advancement for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have previously undergone treatment with BTK inhibitors [1][2] Group 1: Approval and Indication - Pirtobrutinib has received approval from the National Medical Products Administration (NMPA) in China for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy including a BTK inhibitor [1] - The drug was previously approved by the FDA in January 2023 and is indicated for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies, including BTK inhibitors, by October 2024 in China [1] Group 2: Clinical Study Results - The approval is based on the results of the international, multicenter, randomized controlled BRUIN-CLL-321 Phase III study, which included 238 patients previously treated with covalent BTK inhibitors [2] - Pirtobrutinib significantly extended the median progression-free survival (PFS) to 14.0 months compared to 8.7 months for the control group (HR=0.54) and had a lower treatment-related discontinuation rate of 5.2% versus 21.1% [2] Group 3: Market Impact and Strategy - The approval of Pirtobrutinib for CLL/SLL in China is a major breakthrough, allowing local patients to benefit from this global innovation [2] - The company aims to leverage its leading brand and expertise in the oncology field to accelerate the accessibility of this innovative therapy for more patients in need [2]

Core Viewpoint - The approval of the new indication for the non-covalent BTK inhibitor, Pirtobrutinib (捷帕力®), by the NMPA represents a significant advancement for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously undergone systemic treatment including BTK inhibitors [1][2] Group 1: Product Approval and Mechanism - Pirtobrutinib has been approved for use in adult CLL/SLL patients who have received at least one systemic treatment including a BTK inhibitor [1] - It is a highly selective kinase inhibitor that employs a novel binding mechanism to restore BTK inhibition in patients previously treated with covalent BTK inhibitors [1] - The drug was first approved by the FDA in January 2023 and received approval in China in October 2024 for use in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two systemic treatments [1] Group 2: Clinical Study Results - The approval is based on the results of the international, multicenter, randomized controlled BRUIN CLL-321 Phase III study, which included 238 patients [2] - The study compared the efficacy and safety of Pirtobrutinib monotherapy with either IdelaR or BR regimens in patients previously treated with covalent BTK inhibitors [2] - Results showed that Pirtobrutinib significantly extended the median progression-free survival (PFS) to 14.0 months compared to 8.7 months for the control group, with a hazard ratio (HR) of 0.54, and had a lower treatment-related discontinuation rate of 5.2% versus 21.1% [2] Group 3: Market Impact and Future Plans - The approval of Pirtobrutinib for CLL/SLL in China is a major breakthrough, allowing local patients to benefit from this global innovation [2] - The company aims to leverage its leading brand and expertise in oncology to accelerate the accessibility of this innovative therapy for more cancer patients in need [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 1 此次新適應症獲批是基於國際多中心、隨機對照的BRUIN CLL-321 III期研究結 果。BRUIN CLL-321是全球首個在既往接受過共價BTK抑制劑(cBTKi)治療的 CLL/SLL患者中開展的隨機III期試驗，共納入238例患者，旨在對比匹妥布替尼 單藥治療與研究者選擇的idelalisib聯合利妥昔單抗（「IdelaR」）或苯達莫司汀聯合 利妥昔單抗（「BR」）方案的療效與安全性。研究結果顯示，匹妥布替尼顯著延長 患者的中位無進展生存期(PFS)（14.0個月vs 8.7個月，風險比[HR]=0.54），且因治 療相關不良事件導致的停藥率更低(5.2% vs 21.1%)，進一步驗證了其在共價BTK 抑制劑經治人群中的療效與耐受性優勢3 。 捷帕力® （匹 ...

Core Viewpoint - The article discusses the competitive landscape of GLP-1 drugs, focusing on East China Pharmaceutical's initiation of a head-to-head Phase III clinical trial for its dual-target drug HDM1005 against Innovent Biologics' Ma Shidu peptide, aiming to establish dominance in the diabetes and weight management sectors [4][6]. Group 1: Clinical Trial Details - East China Pharmaceutical has launched a head-to-head Phase III clinical trial for HDM1005, targeting approximately 912 patients with type 2 diabetes who have inadequate blood sugar control despite treatment with metformin or SGLT2 inhibitors [4]. - The trial design is multi-center, randomized, open-label, and includes a positive drug control, which aligns with clinical practices and reduces variability in administration frequency [4][5]. Group 2: Market Focus and Expectations - The market is particularly interested in three aspects following the initiation of the Phase III trial: the ability of HDM1005 to outperform competitors in combined endpoints of blood sugar reduction and weight loss, the profile of adverse reactions especially gastrointestinal issues and discontinuation rates, and the implications of dose escalation, adherence, and long-term benefits for commercialization [5]. - The approach taken by East China Pharmaceutical is not merely to advance a Phase III trial but to directly compete for market share in the dual-target weekly formulations for diabetes and weight management [6].

Group 1: Market Overview - The Hang Seng Index opened high but closed down 384 points, or 1.44%, at 26,381 points, with significant selling pressure observed throughout the day [3][4] - The market saw a total turnover of 25.93 billion HKD, with net outflow from northbound trading amounting to 736.6 million HKD [3] Group 2: Company Performance - NIO's subsidiary GeniTech secured over 2.257 billion RMB in investment from Chinese investors, maintaining a 62.7% controlling stake post-transaction [12] - New World Department Store China reported a 3.93 times increase in interim profit to 15.327 million HKD, despite a 12.44% decrease in revenue to 536 million HKD [13] - Chow Tai Fook Jewelry Group announced a 15.26% increase in interim profit to 1.334 billion HKD, with revenue rising 5.9% to 12.827 billion HKD [14] - Baidu reported a 65.68% decrease in net profit to 1.782 billion RMB for the fourth quarter, with total revenue declining 4.06% to 32.74 billion RMB [15] Group 3: Industry Developments - Hong Kong Exchanges and Clearing is exploring the development of a multi-asset tokenization platform, contingent on technological capabilities and market demand [7] - The People's Bank of China issued a notice to enhance the management of RMB cross-border interbank financing, aiming to improve transparency and stability in offshore RMB liquidity [10] - The Hong Kong government plans to inject 10 billion HKD into the Hong Kong-Shenzhen Innovation and Technology Park and the New Territories Science Park to bolster public-private partnerships [9]

Core Insights - The introduction of PD-1 inhibitors in 2014 marked a significant turning point in the fight against cancer, with Bristol-Myers Squibb's Opdivo and Merck's Keytruda leading the charge in immunotherapy [1][3] - The competition between Opdivo and Keytruda has evolved over the years, with Keytruda ultimately becoming the top-selling drug globally by 2024 [21][22] Historical Context - The history of cancer immunotherapy began with William Coley's discovery in the late 19th century, which was followed by a long period of stagnation until the late 20th century when key immune cells were identified [4] - The discoveries of James Allison and Tasuku Honjo regarding CTLA-4 and PD-1, respectively, laid the groundwork for the development of PD-1 inhibitors [5][10] Drug Development - Opdivo was developed with strong backing from Bristol-Myers Squibb after acquiring Medarex in 2009, leading to its approval in Japan in 2014 [12] - Keytruda's development faced initial setbacks but was revitalized by Merck's strategic decision to conduct an unprecedented "super I phase" trial, leading to its approval shortly after Opdivo [14][15][16] Market Dynamics - In 2016, a critical competition occurred between Opdivo and Keytruda in the non-small cell lung cancer (NSCLC) market, which is the largest segment in oncology [17] - BMS's failure in the CheckMate-026 trial led to a significant drop in Opdivo's market position, while Merck's more selective approach in the KEYNOTE-024 trial resulted in Keytruda's success [18][19][20] Sales Performance - By 2024, Keytruda's sales reached $29.5 billion, marking an 18% increase and solidifying its position as the top-selling drug globally [21] - Opdivo, while still a major player, saw its sales decline but remained above the $10 billion mark, maintaining its status as a heavyweight in the market [22][23] Competitive Landscape - The global PD-1 inhibitor market is highly competitive, with 527 candidates in development as of early 2025, including 20 approved drugs [26][29] - In China, the market is characterized by intense competition among local manufacturers, with significant price reductions due to national healthcare negotiations [30][31] Future Outlook - Keytruda's core patent is expected to expire in 2028, potentially leading to a significant drop in sales as biosimilars enter the market [32] - A new challenger, Ivonescimab, has shown superior efficacy compared to Keytruda in clinical trials, indicating a shift towards dual-target therapies in cancer treatment [33][35]

Investment Rating - The industry investment rating is maintained at "Overweight" [7] Core Insights - The report highlights the continuous upgrading of policies in the Heilongjiang biomanufacturing industry, focusing on innovative traditional Chinese medicine and innovative medical devices [4] - The report emphasizes the significant revisions to the Drug Administration Law, which provides institutional support for pharmaceutical innovation and high-quality development [4] - The report identifies three major transformations in China's innovative drug business development (BD) in 2026: technology output combined with product authorization, platform cooperation, and global parallel innovation [8] Summary by Sections Industry Performance - Over the past 12 months, the industry has shown a relative return of -7.06% compared to the CSI 300 index, with an absolute return of 11.53% [3] Investment Highlights - The report notes that BD transactions in the pharmaceutical sector are focused on unmet clinical needs, technological differentiation, and global value [6] - Key areas of focus include oncology therapies such as dual antibodies, ADCs, and TCE combinations, with significant financial agreements highlighted, such as a $650 million upfront payment for a PD-1/VEGF dual antibody [6] - The metabolic disease sector is centered on long-acting GLP-1 and small nucleic acid precision therapies, with notable collaborations resulting in substantial upfront payments and potential total amounts [6] Company-Specific Developments - Companies like Andover Pharmaceuticals and Frontier Biotech have secured significant collaborations with major pharmaceutical firms, indicating a trend towards platform-based cooperation and technology output [7] - Specific collaborations include a $1.05 billion deal for a CTLA-4 inhibitor and a $400 million agreement for small nucleic acid drugs, showcasing the growing interest in innovative therapies [7] - The report suggests monitoring companies such as Rebio Biotech and WuXi AppTec for their advancements in small nucleic acids and platform capabilities [8]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [5] Core Insights - The underlying logic of the current pharmaceutical industry era is innovation and international expansion, with a focus on innovative drugs and technology-driven sectors [2][3] - The report highlights the strong performance of the CRO market and suggests a dual investment strategy focusing on both "0 to 1" technology innovation and low-position stocks [2][3] - The report emphasizes the ongoing trend of BD (Business Development) transactions in innovative drugs, with significant growth expected in 2026 [4][15] Summary by Sections 1. Key Events in the Pharmaceutical Industry During the Spring Festival - Innovative drug BD transactions have seen a strong start, with significant overseas development and registration progress for key products [13][14] - The total amount of BD transactions for innovative drugs in China for 2026 has already surpassed one-third of the total for 2025 [15] - The revision of the National Essential Medicines List Management Measures may signal changes in the essential medicines directory [28] 2. Pharmaceutical Market Review and Hotspot Tracking - The pharmaceutical sector's performance was relatively weak, with a weekly decline of 0.81%, ranking 20th among all industries [34][38] - The total trading volume for pharmaceuticals was 401.12 billion yuan, accounting for 3.83% of the total market, below the historical average of 7.09% [55] - The report notes a rising valuation level for the pharmaceutical industry, with a PE ratio of 29.25, which is below the historical average [52] 3. Stock Performance Review - The report lists the top-performing stocks, including Dongyangguang and Zhendemedical, while highlighting the underperformers like Huayuan Biology and *ST Sailong [58][59]

Group 1 - The top three companies by Hong Kong Stock Connect holding ratio are Haotian International Investment (71.36%), China Telecom (71.32%), and Green Power Environmental (68.88%) [1][2] - Tencent Holdings, Xiaomi Group-W, and Meituan-W have seen the largest increases in holding amounts over the last five trading days, with increases of +1.391 billion, +983 million, and +931 million respectively [1][2] - The companies with the largest decreases in holding amounts over the last five trading days include WuXi Biologics (-481 million), Zijin Mining (-447 million), and Southern Hengsheng Technology (-344 million) [1][4] Group 2 - The latest holding ratios for the top 20 companies in Hong Kong Stock Connect show Haotian International Investment with 7.919 billion shares, China Telecom with 9.900 billion shares, and Green Power Environmental with 0.279 billion shares [2] - The top 10 companies with the largest increases in holding amounts over the last five trading days include China Petroleum & Chemical Corporation (+315 million) and Zhaoyi Innovation (+309 million) [2][4] - The top 10 companies with the largest decreases in holding amounts include Pop Mart (-294 million) and SenseTime-W (-277 million) [4]