信達生物製藥 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。 中國，香港 2026年3月12日 INNOVENT BIOLOGICS, INC. 於本公告刊發日期，董事會包括主席兼執行董事俞德超博士及執行董事奚浩先生 及張倩女士；及獨立非執行董事Charles Leland Cooney博士、許懿尹女士、Gary Zieziula先生、陸舜博士、陳樹云先生及Stephen A. Sherwin博士。 董事會召開日期 信達生物製藥（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈，本公司將於 2026年3月26日（星期四）舉行董事會會議，以考慮及批准（其中包括）本公司及其 附屬公司截至2025年12月31日止年度之全年業績及其發佈，並考慮建議派發末期 股息（如有）。 承董事會命 信達生物製藥 主席兼執行董事 俞德超博士 （於開曼群島註冊成立的有限公司） （股份代號：1801） ...

Core Viewpoint - The global pharmaceutical industry is experiencing a new competitive landscape as multinational companies release their 2025 performance reports, with Johnson & Johnson leading in total revenue at $94.193 billion, followed by Eli Lilly with a remarkable growth rate of 44% [1][2]. Group 1: Financial Performance of Major Pharmaceutical Companies - Johnson & Johnson achieved total revenue of $94.193 billion, with its innovative pharmaceuticals and medical technology segments generating $60.401 billion (+6%) and $33.792 billion (+6.1%) respectively [2]. - Eli Lilly reported a total revenue of $65.179 billion, marking a significant growth of 44% [2]. - Roche, Merck, Pfizer, AbbVie, AstraZeneca, and Novartis also showed upward revenue trends, contributing to the steady growth of the global pharmaceutical industry [1][2]. Group 2: Strategic Adjustments and Leadership Changes - Sanofi appointed Belén Garijo as the new CEO, focusing on enhancing the productivity and innovation capabilities of the R&D department [3]. - Merck announced a reorganization of its pharmaceutical business into two segments: oncology and specialty, aiming to maintain its leadership in cancer treatment [3]. - The global pharmaceutical industry is expected to see continued growth differentiation, with only Eli Lilly providing a double-digit revenue growth forecast for 2026 [3]. Group 3: Competition for the "King of Drugs" Title - In 2025, Eli Lilly's Tirzepatide secured the title of "King of Drugs" with a revenue contribution of $36.5 billion, while Merck's Keytruda generated $31.68 billion, marking a 7% increase [6][7]. - Novo Nordisk's Semaglutide followed closely with $36.1 billion in sales, reflecting over 10% growth [7]. - The GLP-1 drug market is becoming increasingly competitive, with both Eli Lilly and Novo Nordisk dominating the landscape [8]. Group 4: Performance in the Chinese Market - AstraZeneca maintained its leading position in the Chinese market with a revenue of $6.654 billion, representing a 4% increase [12]. - Roche and Novartis were among the top three companies in terms of revenue growth in China, with Roche achieving a 10% increase [13]. - Companies are increasingly focusing on local partnerships and innovations to enhance their market presence in China [14]. Group 5: Patent Expiration and New Growth Opportunities - Many multinational pharmaceutical companies are facing significant risks due to impending patent expirations, with some companies exposed to risks as high as 70% [16]. - The industry is witnessing a surge in business development activities, with 142 innovative drug transactions reported in 2025, marking a new high [17]. - Companies are increasingly seeking new growth avenues through mergers, acquisitions, and collaborations to mitigate the impact of patent cliffs [19].

Core Viewpoint - In the past year, Innovent Biologics has achieved breakthroughs in multiple disease areas, marking significant advancements in the biopharmaceutical industry in China [1] Group 1: Product Developments - The launch of Tislelizumab (替妥尤单抗 N01) fills a 70-year gap in the treatment of thyroid eye disease in China [1] - Ma Shidu Peptide (玛仕度肽) is recognized as the world's first approved GCG/GLP-1 dual-target weight loss and blood sugar-lowering drug, showcasing the impact of domestic innovative drugs in global academic circles [1] Group 2: Market and Regulatory Environment - Continuous reforms in drug regulation, medical insurance, and capital markets have facilitated the rapid translation of research outcomes into patient benefits [1] Group 3: Strategic Direction - Positioned at the new starting point of the 14th Five-Year Plan, Innovent Biologics aims to enhance its independent R&D capabilities and adhere to a strategy of "innovation as the cornerstone and globalization" [1] - The company plans to deepen domestic and international collaborations to steadily advance towards becoming a world-class biopharmaceutical company [1]

Group 1 - The core viewpoint of the news highlights the recent downturn in the Asia-Pacific market, particularly in the Hong Kong pharmaceutical sector, with the Hong Kong Stock Connect Innovation Drug ETF (159570) experiencing a nearly 2% decline, despite a significant net subscription of 210 million yuan and a total scale exceeding 23.1 billion yuan [1][3] - The high-level meeting has officially categorized innovative drugs as an "emerging pillar industry," emphasizing the acceleration of commercial health insurance development and the promotion of high-quality development in innovative drugs [3] - The approval of Hansoh Pharmaceutical's application for the listing of Amivantamab tablets marks a significant milestone, as it is the first domestically developed third-generation EGFR-TKI in China, with five approved indications since its initial approval in March 2020 [3] Group 2 - In business development news, China Biologic Products announced an exclusive licensing agreement with Sanofi for Rovafatinib, a novel oral small molecule JAK/ROCK inhibitor, with potential payments totaling up to 1.53 billion USD, including an upfront payment of 135 million USD [4] - The Hong Kong Stock Connect Innovation Drug ETF (159570) saw most of its index's popular stocks decline, with notable drops including 5% for 3SBio and over 4% for CanSino Biologics, while Hansoh Pharmaceutical saw a slight increase due to new drug news [4] - The innovative drug sector is experiencing short-term volatility, but the long-term growth potential remains intact, with a focus on the globalization of Chinese pharmaceutical companies and the advancement of innovative technologies [6][9] Group 3 - The focus of the market has shifted from the ability to enter overseas markets to the progress of products in overseas clinical deployments, with key data readouts and milestone achievements becoming critical for future evaluations [7] - Chinese companies are making breakthroughs in frontier technologies such as small nucleic acids and cell therapies, positioning themselves as core assets in global transactions [8] - Leading innovative drug companies are entering a positive cycle of product commercialization and reinvestment in research and development, with expectations for significant performance improvements in the upcoming earnings period [9]

Investment Rating - The report indicates a positive outlook for the overseas pharmaceutical industry, particularly highlighting the collaboration between China National Pharmaceutical Group (中生) and Sanofi on JAK/ROCK inhibitors, and the approval of a new indication for Innovent Biologics' BTK inhibitor in China [1][4][6]. Core Insights - The report emphasizes significant revenue growth projections for companies such as Crystal Holding, which anticipates revenue of at least 780 million RMB in 2025, representing a year-on-year increase of approximately 193%. Additionally, He Yu expects revenue of 612 million RMB, a 21% increase year-on-year [5][6]. - The collaboration between China National Pharmaceutical Group and Sanofi is expected to yield a total of 1.35 billion USD in upfront payments and potential milestone payments of up to 1.395 billion USD for the global development and commercialization of the JAK/ROCK inhibitor [2][6]. - The report also notes that the BTK inhibitor from Innovent Biologics has received approval for a new indication in adult chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients who have undergone prior treatment [2][6]. Summary by Sections 1. Overseas Pharmaceuticals - The report highlights the collaboration between China National Pharmaceutical Group and Sanofi regarding JAK/ROCK inhibitors and the approval of a new indication for Innovent Biologics' BTK inhibitor [1][4][6]. - The healthcare index has seen a decline of 6.24%, underperforming the Hang Seng Index by 2.23 percentage points [4]. 2. Performance Updates - Crystal Holding expects to achieve a revenue of at least 780 million RMB in 2025, with a year-on-year growth of approximately 193%, and a net profit of at least 100 million RMB, marking a turnaround from losses [5]. - He Yu anticipates a revenue of 612 million RMB in 2025, reflecting a 21% year-on-year increase, with a net profit of 55 million RMB, up 95% year-on-year [5]. 3. Key Events - The report discusses the successful Phase III clinical trial of Roche's BTK inhibitor Fenebrutinib for relapsing multiple sclerosis, which has shown statistically significant results [7]. - The FDA has granted priority review status to Priovant Therapeutics' TYK2/JAK1 inhibitor for dermatomyositis, which, if approved, would be the first targeted therapy for this condition [8]. 4. Investment Recommendations - The report suggests focusing on innovative drug companies with active commercialization and business development opportunities, including companies like BeiGene, Innovent Biologics, and others [9]. - It also highlights the ongoing transformation in the pharmaceutical sector, with companies like 3SBio and Hansoh Pharmaceutical making strides in their innovative pipelines [9].

Investment Rating - The report maintains an "Overweight" rating for the overseas pharmaceutical industry, indicating a positive outlook for the sector's performance compared to the overall market [5][10]. Core Insights - The report highlights significant developments in the pharmaceutical sector, including a licensing agreement between China National Pharmaceutical Group (Sinopharm) and Sanofi for the JAK/ROCK inhibitor, and the approval of a new indication for Innovent Biologics' BTK inhibitor in China [1][2]. - Performance forecasts for companies such as Crystal Holding and He Yu indicate substantial revenue growth, with Crystal Holding expected to achieve at least 780 million RMB in revenue for 2025, representing a year-on-year increase of approximately 193% [6][7]. Summary by Sections 1. Overseas Pharmaceuticals - Sinopharm and Sanofi have entered into an exclusive licensing agreement for the global development, production, and commercialization of the JAK/ROCK inhibitor, with potential milestone payments totaling up to 1.395 billion USD [2][7]. - Innovent Biologics' BTK inhibitor, Jiepalit (Pirtobrutinib), has received NMPA approval for a new indication in adult patients with chronic lymphocytic leukemia (CLL) who have previously undergone systemic treatment [2][7]. - Roche's BTK inhibitor Fenebrutinib has successfully met primary endpoints in a Phase III trial for relapsing multiple sclerosis, potentially becoming the first effective oral treatment for both relapsing and primary progressive forms of the disease [3][8]. 2. Performance Updates - Crystal Holding anticipates a revenue of no less than 780 million RMB in 2025, with a net profit of at least 100 million RMB, marking a turnaround from losses [6][7]. - He Yu expects to achieve 612 million RMB in revenue for 2025, reflecting a 21% year-on-year growth, with net profit projected at 55 million RMB, a 95% increase [6][7]. 3. Investment Recommendations - The report suggests focusing on innovative pharmaceutical companies with active commercialization and business development opportunities, including companies like BeiGene, Innovent Biologics, and others [10]. - It also highlights the importance of monitoring clinical progress in key pipelines for companies transitioning towards innovation [10].

Core Viewpoint - Recently, Innovent Biologics (1801.HK) announced a global strategic collaboration with Eli Lilly to jointly advance the global development of innovative drugs in oncology and immunology [1] Group 1: Strategic Collaboration - Innovent will lead the research and development from drug discovery to clinical concept verification in China, while Eli Lilly will have exclusive development and commercialization rights outside Greater China [1] - Innovent will receive an upfront payment of $350 million and could earn up to approximately $8.5 billion in milestone payments based on subsequent development, regulatory, and commercialization achievements [1] - Innovent will also enjoy a tiered sales share of net sales outside Greater China for the related products [1] Group 2: Financial Performance - Innovent disclosed that it expects total product revenue to reach approximately RMB 11.9 billion in 2025, a year-on-year increase of about 45%, marking its first time surpassing the RMB 10 billion threshold [1] Group 3: Market Reaction and Concerns - Despite the positive financial outlook, the secondary market reacted coldly, with Innovent's stock price declining by 14.73% from February 24 to March 5, exceeding the industry average decline of 12.24% [3] - The company faces increasing pressure from intensified competition in the innovative drug sector and ongoing healthcare cost control measures [5] Group 4: Core Product Performance - Innovent's cornerstone product, PD-1 inhibitor Tyvyt (sintilimab), has seen a significant slowdown in growth after a peak in 2020, with sales dropping nearly 30% in 2022 [7][9] - The sales revenue for Tyvyt was approximately RMB 3.82 billion in 2024, with a projected growth rate of only about 5% for 2025 [9] Group 5: Competitive Landscape - The PD-1 market is becoming increasingly competitive, with similar products from competitors like BeiGene and Hengrui rapidly catching up in terms of indications and healthcare coverage [9] - Innovent's new GLP-1 drug, Ma Shidu (mounjaro), is entering a highly competitive market, facing aggressive price cuts from major players like Eli Lilly and Novo Nordisk [10][11] Group 6: Strategic Adjustments - Innovent is adjusting its strategy by focusing on core projects and optimizing cash flow, which may involve reducing its research pipeline to concentrate resources on commercially viable projects [18] - The company aims to stabilize its fundamentals while nurturing the next growth driver to achieve its revenue target of RMB 20 billion by 2027 [18]

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry [5] Core Viewpoints - Short-term fluctuations do not change the long-term growth trajectory of the innovative drug sector. Despite recent market volatility, the underlying logic for medium to long-term growth remains intact, driven by globalization, technological breakthroughs, and industry upgrades [8][12] - The focus has shifted from "can we go global" to "what progress has been made after going global," emphasizing the importance of overseas clinical deployment and milestone achievements for innovative drugs [13][14] - Breakthroughs in frontier technologies, particularly in small nucleic acids and CAR-T therapies, position Chinese companies to become core global assets [18][20] - The commercialization of innovative drugs is expected to lead to a profitability inflection point, with key companies entering a positive cycle of product volume growth and reinvestment in R&D [22] Summary by Sections 1. Short-term Fluctuations, Long-term Growth - The innovative drug sector has experienced significant volatility due to concentrated expectations and emotions, but the long-term growth trend remains unchanged [8][12] - The valuation of leading companies has reached reasonable levels, suggesting potential investment opportunities as market sentiment stabilizes [12] 1.1 Focus on Globalization Progress - The emphasis has shifted to the progress of products in overseas clinical trials, with a focus on key data readouts and milestone achievements [13][14] - Domestic bispecific antibodies are accelerating their global clinical trials, becoming core trading assets in the context of expiring patents for PD-(L)1 products [13] 1.2 Breakthroughs in Frontier Technologies - Chinese companies are leading in small nucleic acids and CAR-T therapies, with significant advancements in delivery technologies expanding treatment options beyond rare diseases [18] - In vivo CAR-T therapies have shown preliminary clinical effectiveness, with a growing number of transactions indicating a shift towards mainstream adoption [20] 1.3 Commercialization Driving Profitability - Leading innovative drug companies are entering a cycle of product volume growth that supports R&D reinvestment, with expectations for exceeding market performance in 2023 [22] - The upcoming earnings period in March-April 2026 is seen as a critical validation point for the sector [22] 2. Global New Drugs: Highlights in Autoimmunity and Oncology - The report highlights the approval of the world's first PD-L1/TGF-β bispecific antibody, showcasing the R&D capabilities of domestic companies [26][27] - The successful launch of innovative drugs in critical therapeutic areas reflects the growing strength of domestic pharmaceutical companies in addressing unmet medical needs [26][27]

Group 1 - Morgan Stanley increased its stake in Innovent Biologics (01801) by 408,630 shares at a price of HKD 84.9352 per share, totaling approximately HKD 34.7071 million [1] - After the increase, Morgan Stanley's total shareholding in Innovent Biologics reached approximately 86,908,100 shares, representing a 5% ownership stake [1]

Group 1 - JPMorgan Chase & Co. increased its stake in Innovent Biologics (01801.HK) by purchasing 408,600 shares at an average price of HKD 84.9352 per share, totaling approximately HKD 34.71 million [1] - Following this transaction, JPMorgan's total holdings in Innovent Biologics rose to 86,908,068 shares, with the ownership percentage increasing from 4.98% to 5.00% [1]