Core Viewpoint - The Chinese biotechnology sector is entering a turning point this year, with stabilizing fundamentals and resilient innovation foundations, while financing activities are recovering [1] Group 1: Market Conditions - The report indicates that the biotechnology sector in China will experience range-bound fluctuations in the first half of the year due to a scarcity of catalysts and limited high-conviction investment themes [1] - Risk appetite remains unstable, impacting the overall market sentiment in the sector [1] Group 2: Future Outlook - The next growth phase is expected to begin with significant data releases, increased business development activities, and visible licensing transactions [1] - Most of these events are concentrated around the second half of 2026, suggesting that further industry re-evaluation should be delayed rather than interrupted [1] Group 3: Company Coverage - Morgan Stanley has resumed coverage of Innovent Biologics, assigning an "Overweight" rating with a target price of HKD 130 [1]

Core Insights - The approval of the non-covalent BTK inhibitor, Jebatilib (Pirtobrutinib), for a new indication in treating adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously undergone at least one systemic treatment including BTK inhibitors is a significant milestone for the company and the industry [1][2] Group 1: Regulatory Approval - Jebatilib has received approval from the National Medical Products Administration (NMPA) in China for a new indication in CLL/SLL treatment [1] - The drug was previously approved by the FDA in January 2023 and is set to be available for adult patients with relapsed or refractory mantle cell lymphoma (MCL) in China starting October 2024 [1] Group 2: Clinical Research - The new indication 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 Jebatilib 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 was lower for Jebatilib at 5.2% compared to 21.1% for the control group, highlighting its efficacy and tolerability in patients previously treated with covalent BTK inhibitors [2] Group 3: Market Impact - The approval of Jebatilib for CLL/SLL represents a major breakthrough in the field, allowing Chinese 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 cancer patients in need [2]

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 Insights - The IBI EXPO 2026 Biopharmaceutical Innovation Conference will provide a high-level platform for communication and collaboration in the innovative drug industry [1] - Recent favorable news in the innovative drug sector includes a significant increase in licensing agreements, with Chinese companies signing $137.7 billion in deals in 2025, nearly a tenfold increase from 2021 [1][2] - The trend of Chinese biopharmaceutical companies entering international licensing agreements is accelerating, with major collaborations such as the $8.85 billion deal between Innovent Biologics and Eli Lilly [1][5] Market Focus - The IBI EXPO 2026 conference serves as a catalyst for the innovative drug sector, highlighting the substantial growth in licensing agreements and the transition from research investment to commercial realization [2] - The number of licensing agreements reached 186 in 2025, with a total transaction value of $137.7 billion, marking a record high for the past decade [3][5] - Companies like Innovent Biologics and Rongchang Biopharma are transitioning from loss to profit, indicating a clear improvement in the overall profitability of the industry [2][3] Broker Insights - Open Source Securities notes that the period from 2017 to 2026 is a "golden decade" for Chinese pharmaceutical companies, with licensing agreements skyrocketing from $2.562 billion in 2017 to $137.7 billion in 2025 [3] - The overall revenue growth in innovative drugs is evident, with over 70% of companies reporting positive revenue growth in 2025, showcasing strong commercial capabilities [3] - The innovative drug sector has seen a price correction over the past two quarters, but long-term prospects remain positive, suggesting an increase in sector allocation [3] Related Industries - The innovative drug sector is transitioning from a research investment phase to a commercialization phase, with significant implications for the CXO (Contract Research Organization) industry, which is expected to benefit from increased orders [5] - The new business model of external licensing is expected to enhance the early-stage research pipeline, benefiting companies involved in drug discovery and clinical trials [4][5] - The trend of Chinese innovative drugs "going global" is becoming systematic, with major collaborations indicating a shift towards international development [5] Industry Chain Companies - Heng Rui Medicine is a representative company in the domestic chemical innovative drug sector, with a diverse pipeline and ongoing internationalization efforts [7] - Sanofi Biopharma has received approval for its self-developed monoclonal antibody, further enriching its commercial product pipeline [7] - Companies like Rongchang Biopharma and Ailis are demonstrating strong revenue growth and successful international collaborations, indicating a positive trend in the innovative drug sector [7][8]

Group 1 - Morgan Stanley increased its stake in Innovent Biologics (01801) by 585,900 shares at a price of HKD 79.232 per share, totaling approximately HKD 46.422 million [1] - After the increase, the total number of shares held by Morgan Stanley is approximately 87,217,600, representing a stake of 5.02% [1]

Core Viewpoint - JPMorgan Chase increased its stake in Innovent Biologics (01801) by acquiring 585,900 shares at a price of approximately HKD 79.23 per share, totaling around HKD 46.42 million, resulting in a new holding of approximately 87.22 million shares, representing a 5.02% ownership stake [1] Group 1 - JPMorgan Chase's acquisition of 585,900 shares indicates a strategic investment in Innovent Biologics [1] - The purchase price of HKD 79.23 per share reflects the current market valuation of Innovent Biologics [1] - The total investment amount of HKD 46.42 million signifies JPMorgan's confidence in the company's future prospects [1] Group 2 - Following the acquisition, JPMorgan's total shareholding in Innovent Biologics reached approximately 87.22 million shares [1] - The updated ownership percentage of 5.02% positions JPMorgan as a significant stakeholder in Innovent Biologics [1]

Core Viewpoint - Morgan Stanley increased its stake in Innovent Biologics (01801) by purchasing 585,900 shares at a price of HKD 79.232 per share, totaling approximately HKD 46.422 million, raising its ownership to about 87.2176 million shares, which represents a 5.02% stake [1] Group 1 - Morgan Stanley's recent purchase of shares indicates a positive outlook on Innovent Biologics' future performance [1] - The total investment made by Morgan Stanley in this transaction is approximately HKD 46.422 million [1] - Following the acquisition, Morgan Stanley's total shareholding in Innovent Biologics is now approximately 87.2176 million shares [1]