科伦博泰生物-B(06990)发布公告，本公司三款产品，即ADC Sacituzumab Tirumotecan(sac-TMT，亦称 SKB264/MK-2870)(商品名：佳泰莱)、西妥昔单抗N01注射液(前称A140)(商品名：达泰莱)及 Tagitanlimab(亦称A167)(商品名：科泰莱)，已获纳入国家医疗保障局及中国人力资源和社会保障部于 2025年12月7日公布的国家医保目录。值得注意的是，ADC Sacituzumab Tirumotecan有两项适应症获纳 入国家医保目录。 ...

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份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。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 持續關連交易 緒 言 茲提述本公司日期為2023年6月29日的招股章程及本公司日期為2024年 8月19日、2024年8月30日 及2025年2月12日有關若干持續關連交易的公 告。(1) 2025年市場管理服務框架協議及(2)經修訂輔助研發服務框架協 議（統 稱「現有持續關連交易協議」）均 將 於2025年12月31日 到 期。 – 1 – 鑒 於 上 述 情 況，本 公 司 已 於2025年12月15日 訂 立(1)2026年市場管理服務 框 架 協 議，(2)2026年輔助研發服務框架協議及(3)2026年 設備及物資購 銷 框 架 協 議（統 稱「科倫藥業持續關連交易」），各 項 協 議 均 自2 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The 2025 National Medical Insurance Negotiation results were announced, with 114 new drugs added to the medical insurance directory, achieving an overall success rate of 88%, the highest in nearly seven years, with a maximum price reduction of 94 [4][19] - The newly added drugs include monoclonal antibodies, bispecific antibodies, ADCs, siRNA, and small molecules, indicating a strong focus on innovative therapies [19][32] - The commercial insurance directory has added 19 innovative drugs, which, while not reimbursed by medical insurance, receive support for innovative drug applications, enhancing patient access and benefiting the innovative drug industry [5][24] Summary by Sections 1. National Medical Insurance Negotiation Results - The 2025 medical insurance directory added 114 new drugs, with a success rate of 88% and a maximum price reduction of 94% [4][13] - The total number of drugs in the national medical insurance directory reached 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [16][17] - The directory reflects a significant increase in the inclusion of innovative drugs, with 50 of the new additions classified as category 1 innovative drugs [19][21] 2. Commercial Insurance Directory - The commercial insurance directory added 19 innovative drugs, highlighting their clinical value and innovation [24][28] - The directory includes treatments for diseases such as Alzheimer's, rare diseases in children, and other critical conditions, showcasing a focus on addressing unmet medical needs [24][28] - The support for innovative drugs in the commercial insurance directory aims to fill gaps in patient coverage and enhance the overall healthcare system [25][28] 3. Market Performance - In the second week of December, the pharmaceutical and biotechnology sector declined by 1.04%, underperforming the CSI 300 index by 0.96 percentage points [6][34] - The medical research outsourcing sector showed the highest increase, up by 3.69%, while offline pharmacy and medical circulation sectors experienced the largest declines [6][36] 4. Recommended Companies - The report continues to favor innovative drugs and their supply chain, recommending companies such as Sanofi, Innovent Biologics, and others for investment [7][32]

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

Core Viewpoint - The company has achieved significant milestones in its clinical development, particularly with the TROP2 ADC SKB264 in combination with Keytruda for the treatment of PD-L1 positive non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Development - The OptiTROP-Lung05 trial for SKB264 combined with Keytruda has met its primary endpoint in the Phase III clinical trial for 1L treatment of PD-L1 positive NSCLC [1] - The combination therapy showed statistically and clinically significant improvement in progression-free survival (PFS) compared to Keytruda alone, with a trend observed in overall survival (OS) benefits [1] - The company plans to submit a new indication application for market approval in China based on these results, with a focus on the potential registration progress in 2026 [1] Group 2: Strategic Partnerships - The company has entered into a collaboration with Crescent Biopharma, involving an $80 million upfront payment and up to $1.25 billion in milestone payments for the overseas rights to ITGB6 ADC SKB105 [2] - The partnership also includes an upfront payment of $20 million and up to $30 million in milestones for the introduction of Crescent's PD-1 x VEGF dual antibody CR-001 in China [2] - This collaboration is expected to enhance the company's cash flow and accelerate the clinical development path for SKB105, while the introduction of the dual antibody may synergize with the company's existing ADC assets [2] Group 3: Financial Projections - Following the licensing agreement, the company has revised its 2025 net profit forecast from a loss of 672 million yuan to a loss of 420 million yuan, while maintaining the 2026 forecast at a loss of 173 million yuan [2] - The company maintains an outperform rating based on a DCF model, with a target price of 550 HKD, indicating a potential upside of 33.4% from the current stock price [2]

近日，公司宣布：1)TROP2ADC芦康沙妥珠单抗(SKB264)联合帕博利珠单抗(Keytruda)1L治疗PD-L1阳 性非小细胞肺癌(NSCLC)的国内III期临床OptiTROP-Lung05达到主要终点。2)公司与Crescent Biopharma 达成合作，将ITGB6ADC SKB105海外权益以8,000万美元首付款和高达12.5亿美元的里程碑授予 Crescent，并以2,000万美元首付款和高达3,000万美元里程碑引进Crescent PD-1x VEGF双抗CR-001的中 国权益。 SKB264联合K药成为首个在1L NSCLC中达到III期临床主要终点的"ADC+IO"组合 中金发布研报称，考虑到科伦博泰生物-B(06990)授权首付款收入，基本保持2026年归母净利润预测不 变。该行维持跑赢行业评级，基于DCF模型，维持目标价550港币，较当前股价有33.4%的上行空间。 中金主要观点如下： 公司近况 和Crescent达成双向授权，又一新兴靶点ADC进入视野，同时引入双抗丰富管线 根据公司公告，公司预计此次合作的两款药物将于1Q26开展I/II期单药临床，同时双方有权开发引进 ...

Group 1 - The company maintains its net profit forecast for 2026, considering the upfront payment income from the licensing of Keren Biotechnology-B (06990) [1] - The target price is set at HKD 550, indicating a potential upside of 33.4% from the current stock price [1] - The company has achieved a significant milestone with its TROP2 ADC SKB264 combined with Keytruda in the treatment of PD-L1 positive non-small cell lung cancer (NSCLC) [2][3] Group 2 - The collaboration with Crescent Biopharma involves an upfront payment of USD 80 million and potential milestone payments of up to USD 1.25 billion for ITGB6 ADC SKB105, along with an upfront payment of USD 20 million and up to USD 30 million in milestones for the introduction of PD-1 x VEGF dual antibody CR-001 in China [2] - The SKB264 and Keytruda combination is the first ADC+IO regimen to reach the primary endpoint in the 1L NSCLC setting, showing significant improvement in progression-free survival (PFS) and a trend towards overall survival (OS) benefits [3] - The partnership with Crescent is expected to enhance the company's pipeline and cash flow while exploring the potential of next-generation IO+ADC combinations [4]

Core Viewpoint - Kolon Biotech and Crescent have entered into a collaboration to jointly develop and commercialize new cancer treatment methods, including a novel combination therapy, involving Kolon Biotech's SKB105 and Crescent's CR-001 [1][2] Group 1: Collaboration Details - The collaboration includes global exclusive cross-licensing and joint development of SKB105 and CR-001, with Kolon Biotech granting Crescent exclusive rights for SKB105 outside the US, Europe, and Greater China, while Crescent grants Kolon Biotech exclusive rights for CR-001 in Greater China [1] - Both companies will independently develop other combination therapies for CR-001, which has shown strong anti-tumor activity in preclinical studies [1] Group 2: Financial Terms - Kolon Biotech will receive an upfront payment of $80 million from Crescent, with potential milestone payments totaling up to $1.25 billion and tiered royalties based on SKB105's net sales [2] - Conversely, Crescent will receive an upfront payment of $20 million from Kolon Biotech, with potential milestone payments of up to $30 million and tiered royalties based on CR-001's net sales [2] Group 3: Product Characteristics - SKB105 targets integrin β6 (ITGB6) and is designed to reduce off-target toxicity, with high expression in various solid tumors but low or no expression in most normal tissues, which may lower systemic toxicity and off-target risks [2] - SKB105 is an antibody-drug conjugate (ADC) that combines a fully human IgG1 monoclonal antibody targeting ITGB6 with a clinically validated cleavable linker, utilizing proprietary Kthiol irreversible conjugation technology to enhance drug stability and tumor-specific payload delivery [2] Group 4: Competitive Landscape - Pfizer's Sigvotatug vedotin, acquired through the purchase of Seagen, is currently the fastest progressing ADC targeting ITGB6, with two pivotal Phase III clinical studies initiated for non-small cell lung cancer (NSCLC) [3] - Sigvotatug vedotin has shown promising early clinical data in NSCLC and head and neck squamous cell carcinoma, with significant overall response rates and clinical outcomes reported [3] Group 5: Revenue Projections - The company expects revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025 to 2027, with net profits projected at -622 million, -130 million, and 561 million yuan respectively, maintaining a "buy" rating [3]

2025年股份激励计划旨在为公司建立并完善长期激励机制，吸引并留住参与者以推动集团业务发展及成 功，有效协调股东、公司及参与者的利益，促进共同关注公司的长期发展，并推动持续实现公司战略及 运营目标。 智通财经APP讯，科伦博泰生物-B(06990)发布公告，于2025年12月11日，董事会决议批准建议采纳2025 年股份激励计划。根据中国相关法律法规，2025年股份激励计划的采纳须经股东于公司股东会上审议及 批准。 ...

2025年股份激励计划旨在为公司建立并完善长期激励机制，吸引并留住参与者以推动集团业务发展及成 功，有效协调股东、公司及参与者的利益，促进共同关注公司的长期发展，并推动持续实现公司战略及 运营目标。 科伦博泰生物-B(06990)发布公告，于2025年12月11日，董事会决议批准建议采纳2025年股份激励计 划。根据中国相关法律法规，2025年股份激励计划的采纳须经股东于公司股东会上审议及批准。 ...