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]

Core Viewpoint - The collaboration between the company and Eli Lilly marks another significant licensing deal worth over $8.85 billion, reinforcing the strength of the company's antibody technology platform [1] Group 1: Collaboration Details - The company has entered into a strategic partnership with Eli Lilly to advance global R&D of innovative drugs in oncology and immunology [1] - The agreement includes an upfront payment of $350 million, potential milestone payments of up to $8.5 billion, and a tiered sales revenue sharing structure [1] - The company retains all rights in Greater China while Eli Lilly obtains exclusive global development and commercialization rights outside this region [1] Group 2: Financial Projections and Growth - The company anticipates a revenue growth of approximately 45% year-on-year in 2025, reaching around 11.9 billion RMB, with Q4 2025 expected to generate about 3.3 billion RMB [2] - The product pipeline, including IBI363, IBI343, and IBI324, is projected to drive significant revenue growth, with a combined potential market space exceeding $60 billion [2] - Management expects to generate 8-10 new molecules annually from its early-stage clinical pipeline starting in 2026, aiming to push five products into global Phase III trials by 2030 [2] Group 3: Target Price and Ratings - The target price is maintained at HKD 105, reflecting the potential contributions from the Eli Lilly collaboration and adjustments based on the latest management guidance regarding the Takeda collaboration [3]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 105.00, indicating a potential upside of 17.1% from the current price of HKD 89.65 [1][9]. Core Insights - The company has successfully secured a strategic partnership with Eli Lilly, marking its seventh collaboration and validating its antibody technology platform. This partnership is expected to significantly enhance the company's overseas development of early-stage assets and increase global commercialization certainty [2][7]. - The company anticipates strong commercial growth driven by its comprehensive pipeline in 2026, with projected product revenue growth of approximately 45% year-on-year to RMB 12.505 billion in 2025. Key products are expected to continue providing stable support for revenue growth [7][12]. - The management expects that three key assets, IBI363, IBI343, and IBI324, will enter global Phase III clinical trials, with IBI363 alone projected to contribute over USD 40 billion to the market [7][12]. Financial Forecast Changes - Revenue projections for 2025 have been revised down to RMB 12.505 billion, a decrease of 37.1% from previous estimates, while 2026 revenue is expected to rise to RMB 18.450 billion, an increase of 26.7% [3]. - Gross profit for 2025 is now forecasted at RMB 10.713 billion, down 41.0%, with a gross margin of 85.7%. For 2026, gross profit is expected to increase to RMB 16.064 billion, with a gross margin of 87.1% [3]. - The net profit forecast for 2025 has been significantly reduced to RMB 1.055 billion, a decrease of 87.9%, while 2026 net profit is projected to rise to RMB 3.502 billion, reflecting a 37.8% increase [3]. Stock Performance - The stock has shown a year-to-date increase of 17.57%, with a 52-week high of HKD 107.00 and a low of HKD 35.50, indicating strong market interest [6][11]. Valuation Model - The DCF valuation model estimates the equity value at RMB 161.238 million, translating to a per-share value of HKD 105.00, based on projected free cash flows and a WACC of 9.9% [8][15].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 105.00, indicating a potential upside of 17.1% from the current price of HKD 89.65 [1][9]. Core Insights - The company has successfully secured a strategic collaboration with Eli Lilly, marking its seventh major partnership and validating its antibody technology platform. This collaboration is expected to significantly enhance the company's overseas development of early-stage assets and increase global commercialization certainty [2][7]. - The company anticipates strong commercial growth driven by its oncology and comprehensive pipeline in 2026, with projected product revenue growth of approximately 45% year-on-year to RMB 12.505 billion in 2025. Key products are expected to continue supporting revenue growth [2][7]. - The report highlights the potential market space for key assets, estimating over USD 60 billion, with IBI363 alone contributing more than USD 40 billion. The company is also expected to introduce 8-10 new molecules annually from its innovation pipeline starting in 2026 [2][7]. Financial Forecast Changes - Revenue projections for 2025 have been revised down to RMB 12,505 million, a decrease of 37.1% from previous estimates. However, the 2026 revenue forecast has been increased by 26.7% to RMB 18,450 million, and the 2027 forecast has been raised by 18.6% to RMB 20,830 million [3]. - Gross profit for 2025 is now expected to be RMB 10,713 million, down 41.0% from prior estimates, while the gross profit margin is projected to be 85.7% [3]. - The net profit forecast for 2025 has been significantly reduced to RMB 1,055 million, reflecting an 87.9% decrease from previous estimates, but is expected to rise to RMB 3,502 million in 2026 and RMB 4,341 million in 2027 [3]. Stock Performance - The stock has shown a year-to-date increase of 17.57%, with a 52-week high of HKD 107.00 and a low of HKD 35.50, indicating strong market interest [6][12]. Valuation Model - The discounted cash flow (DCF) valuation model estimates the equity value at RMB 161,238 million, translating to a per-share value of HKD 105.00, based on projected free cash flows and a WACC of 9.9% [8][15].

Core Viewpoint - Morgan Stanley reports that Innovent Biologics (01801) has entered into a strategic partnership with Eli Lilly (LLY.US) to jointly develop new biopharmaceuticals focused on oncology and immunology globally, marking a significant milestone in Innovent's journey towards becoming a global biopharmaceutical company [2] Group 1: Strategic Partnership - The collaboration between Innovent Biologics and Eli Lilly is seen as a positive surprise, highlighting Innovent's strong research and development platform [2] - Morgan Stanley reaffirms Innovent Biologics as a top pick among Chinese biotech companies, maintaining an "Overweight" rating with a target price of HKD 111 [2] Group 2: Long-term Vision - Innovent's management reiterated its long-term vision, benefiting from a dual-engine growth strategy in the areas of generic biologics and oncology drugs [2] - Morgan Stanley remains impressed with Innovent's execution capabilities in its commercial and R&D product lines, as well as its strong business development abilities [2]

Core Viewpoint - The strategic collaboration between Innovent Biologics and Eli Lilly marks their seventh partnership, focusing on the development of innovative drugs in oncology and immunology, with significant financial implications for Innovent [2][5]. Financial Aspects - Innovent will receive an upfront payment of $350 million and may earn up to approximately $8.5 billion in milestone payments related to research, regulatory, and commercialization achievements [2]. - The company’s stock price rose by 7.42% to HKD 85.4 per share, with a market capitalization nearing HKD 150 billion as of February 9 [3]. Historical Context - The partnership dates back to 2015, yielding successful products such as the PD-1 antibody, Sintilimab, and the GLP-1 receptor agonist, MaShidu [4]. - Sintilimab has been a cornerstone of Innovent's commercialization strategy, rapidly entering the domestic market and becoming a key product in their portfolio [4]. Strategic Development - The collaboration emphasizes a new model of business development, focusing on entirely new targets and molecules rather than existing products [2][5]. - Innovent will lead the projects from drug discovery to clinical validation in China, while Eli Lilly retains global rights outside of Greater China [5]. Industry Trends - The partnership reflects a broader trend where multinational pharmaceutical companies are increasingly interested in early-stage innovative assets from Chinese firms, moving away from established clinical pipelines [6]. - This shift is seen as a necessary evolution in the research paradigm, allowing for systematic validation of technologies across multiple targets while managing costs [6]. Future Outlook - Innovent's product revenue is projected to reach approximately CNY 11.9 billion in 2025, marking a 45% year-on-year increase, with significant contributions from its oncology and chronic disease product lines [8]. - The company has three core assets expected to enter or are already in international Phase III clinical trials, with a combined market potential exceeding $60 billion [8][9]. Product Pipeline - The new generation IO therapy, IBI363, is anticipated to have a market potential exceeding $40 billion, while IBI343 and IBI324 are also expected to contribute significantly to revenue, with market potentials of over $8 billion and $15 billion, respectively [9][10].