Core Viewpoint - Kintor Pharmaceutical's stock has seen a significant increase following the approval of its new drug application for SKB105, a targeted antibody-drug conjugate for treating advanced solid tumors [1] Group 1: Company Developments - Kintor Pharmaceutical announced that its IND application for the self-developed targeted integrin β6 (ITGB6) antibody-drug conjugate (ADC) SKB105 (also known as CR-003) has been approved by the NMPA for clinical trials [1] - The company plans to submit an IND application for SKB118/CR-001, a bispecific antibody targeting PD-1 and VEGF, to the NMPA in the near future [1] Group 2: Strategic Partnerships - In December 2025, Kintor Pharmaceutical entered into a strategic collaboration with Crescent Biopharma, Inc. regarding SKB105/CR-003 and SKB118/CR-001 [1] - Under the agreement, Kintor grants Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105/CR-003 outside of Greater China, while Crescent grants Kintor exclusive rights for SKB118/CR-001 within Greater China [1]

Group 1 - The pharmaceutical stocks are experiencing strong performance, with notable increases in share prices for companies such as Genscript Biotech (up 9.9%), Kelun Biotech (up 6.29%), and others [1] - As of January 3, the National Medical Products Administration reported that 76 innovative drugs have been approved for market in China by 2025, significantly surpassing the 48 approved in 2024, marking a historical high [1] - The total amount of authorized transactions for innovative drugs in China is expected to exceed $130 billion in 2025, with over 150 transactions, also a historical high [1] Group 2 - The 44th J.P. Morgan Healthcare Conference is scheduled to take place from January 12 to 15, 2026, in San Francisco, attracting over 8,000 global participants [2] - This conference will feature more than 500 listed companies and thousands of startups, focusing on deep exchanges around "capital + strategy" [2] - Chinese pharmaceutical companies are entering an innovation harvest period, transitioning from a "single market-driven" model to a "global value creation" approach, with the JPM conference serving as a key platform for showcasing clinical data and negotiating overseas collaborations [2]

Group 1 - Company Keren Biotechnology (06990) announced that its antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, has received breakthrough therapy designation from the NMPA for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 1% [1] - The breakthrough therapy designation is granted to drugs that provide effective treatment options for conditions with no effective therapies or demonstrate significant clinical advantages over existing treatments [1] - The designation allows for conditional approval applications and priority review during the drug registration process if certain conditions are met [1] Group 2 - The company previously reported significant improvements in progression-free survival (PFS) and observed a trend in overall survival (OS) in the Phase 3 OptiTROP-Lung05 clinical trial of sac-TMT combined with pembrolizumab for treating PD-L1 positive NSCLC [2] - The OptiTROP-Lung05 study is the first Phase 3 clinical trial to achieve its primary endpoint with an immune combination ADC in first-line treatment of NSCLC [2] - The breakthrough therapy designation will expedite the review and approval process for sac-TMT in this indication [2]

Core Viewpoint - The company, Kelun-Botai Biopharmaceutical-B (06990.HK), has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT in combination with Merck's PD-1 monoclonal antibody, pembrolizumab, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 1% and negative for EGFR mutations and ALK [1][2] Group 1 - The Breakthrough Therapy Designation is granted to drugs that provide effective treatment options where none exist or offer significant clinical advantages over existing therapies [1] - Drugs included in the Breakthrough Therapy program can apply for conditional approval and priority review during the drug licensing application process if they meet relevant criteria [1] Group 2 - The company previously announced results from the Phase 3 OptiTROP-Lung05 clinical trial, which demonstrated statistically and clinically significant improvements in progression-free survival (PFS) as the primary endpoint, with a trend towards benefits in overall survival (OS) [2] - The OptiTROP-Lung05 study is the first Phase 3 clinical trial to achieve its primary endpoint with an immune combination ADC in the first-line treatment of NSCLC [2] - The Breakthrough Therapy Designation for sac-TMT in treating PD-L1 positive NSCLC will facilitate the review and approval process for this indication [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 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 自願公告 核心產品TROP2 ADC蘆 康 沙 妥 珠 單 抗（SAC-TMT） 聯合免疫療法帕博利珠單抗一線治療PD-L1陽 性 局部晚期或轉移性非小細胞肺癌 獲國家藥品監督管理局突破性療法認定 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本公司靶向人滋養細胞表面抗原2(TROP2)的抗體偶聯藥 物(ADC)蘆 康 沙 妥 珠 單 抗（sac-TMT，亦 稱SKB264/MK-2870）（佳 泰 萊® ...

Group 1 - Baidu Group-SW (09888) proposes to spin off Kunlun Chip for independent listing on the Hong Kong Stock Exchange main board [1] - Dali Group Holdings (01921) subsidiary Dali International Industrial Company has obtained a temporary industrial license issued by MIMR [1] - Guofu Hydrogen Energy (02582) has completed the delivery of a total of 424 sets of vehicle-mounted high-pressure hydrogen supply systems to its customers [1] Group 2 - CSPC Pharmaceutical Group (01093) has received clinical trial approval in China for its inhalation powder of Nintedanib [1] - Fantasia Holdings (01777) has entered into a restructuring agreement with Splendid Fortune to sell 409 million shares of Color Life for USD 4.5284 million [1] - China Hongqiao (01378) has made Hongtuo Industrial a wholly-owned subsidiary of Hongchuang Holdings [1] Group 3 - Brainstorm Cell Therapeutics-B (06681) subsidiary has officially signed a cooperation agreement with Beijing Jianguo Medical for a cognitive digital therapy project [1] - Longpan Technology (02465) plans to invest in a lithium iron phosphate production base with an annual capacity of 240,000 tons, with a total investment not exceeding 2 billion yuan [1] - Zhongzheng International (00943) intends to acquire a digital solution company in the beauty industry for HKD 62.5 million, with resumption of trading on January 5 [1] - Kelun-Biotech (06990) has received approval from the National Medical Products Administration for the clinical trial application of its ITGB6 ADC SKB105 new drug [1]

2025年12月，公司与Crescent Biopharma,Inc.就SKB105/CR-003与SKB118(程序性细胞死亡蛋白-1(PD-1)x 血管内皮生长因子(VEGF)双特异性抗体，亦称CR-001)达成战略合作，其中公司授予Crescent在美国、 欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研究、开发、生产和商业化 SKB105/CR-003的独家权利，Crescent则授予公司在大中华地区研究、开发、生产和商业化SKB118/CR- 001的独家权利。公司计划于近期向中国国家药品监督管理局药品审评中心递交SKB118/CR-001的IND 申请。 科伦博泰生物-B(06990)发布公告，公司自主研发的靶向整合素β6(ITGB6)抗体偶联药物 (ADC)SKB105(亦称CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中 心(CDE)批准，用于治疗晚期实体瘤。 ...

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 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 自願公告 ITGB6 ADC SKB105新藥臨床試驗 申請獲國家藥品監督管理局批准 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 自 主 研 發 的 靶 向 整 合 素β6 (ITGB6)抗體偶聯藥物 (ADC) SKB105（亦 稱CR-003）的 新 藥 臨 床 試 驗(IND)申請已獲中國國家藥品 監督管理局(NMPA)藥品審評中心(CDE)批 准，用 於 治 療 晚 期 實 體 瘤。 ...

Core Viewpoint - The article highlights the unprecedented surge in business development (BD) activities in China's biotech sector, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, marking a doubling compared to 2024. This trend reflects the increasing global competitiveness and value of Chinese pharmaceutical assets, while also prompting a deeper examination of transaction quality and product value realization post-agreement [1][2]. Summary by Sections BD Market Dynamics - The BD market in China is experiencing a significant boom, with a projected compound annual growth rate (CAGR) for external BD activities expected to remain in double digits over the next five years, despite a forecasted decline in growth rate [2]. - Key characteristics of future transactions include an increase in late-stage pipeline contributions and a shift from pure technology transfer to models involving "licensing + co-development + commercialization" [2]. Major Transactions - Notable transactions in 2025 include: - Hengrui Medicine's collaboration with GSK, involving a total potential amount of approximately $120 billion, with an upfront payment of $500 million [3]. - Innovent Biologics' agreement with Takeda, with a potential total of $114 billion and an upfront payment of $1.2 billion [3]. - A record-setting deal between 3SBio and Pfizer, with an upfront payment of $12.5 billion and potential milestone payments reaching $48 billion [5][6]. Global Interest in Chinese Biotech - Chinese innovative drugs are gaining significant traction in global markets, with multinational corporations increasingly sourcing early-stage innovation pipelines from China due to cost-effectiveness and potential efficacy [7][8]. - The trend indicates a shift where Chinese biotech firms are evolving from technology providers to value co-creators in the global pharmaceutical landscape [7]. Transaction Models - The dominant transaction model remains "License-out," which accounted for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [10]. - NewCo models are gaining popularity, allowing companies to inject parts of their product pipelines into newly formed entities with foreign capital, reflecting a flexible asset operation strategy [10][11]. Future Outlook - The BD market is expected to continue thriving, driven by the need for multinational companies to replenish their pipelines as many blockbuster drugs face patent expirations, creating a significant market opportunity [15]. - Emerging technologies, particularly in ADCs and bispecific antibodies, are anticipated to dominate future BD transactions, with a notable interest in metabolic and autoimmune products [16][17]. Challenges and Considerations - Despite the growth, challenges remain in ensuring compliance with international standards and protecting intellectual property during global collaborations [13]. - The market is expected to stabilize, with a rational return to expectations regarding BD transactions, as the industry matures and the focus shifts from explosive growth to sustainable value creation [17].

此次三款药物纳入医保，不仅降低了以往高昂的治疗成本，更通过医保报销机制切实缓解患者的经济压 力，让这份"生命希望"真正变得触手可及。针对临床未满足的需求和治疗费用的降低，科伦博泰总经理 兼首席执行官葛均友博士表示，"当你知道自己的创新研究成果可能改变一个疾病领域的治疗格局，能 够填补目前治疗不了的领域时，那种使命感超越了任何商业考量。虽然医保目录内已有同类治疗产品， 但我们愿意以更加亲民的价格推进国产替代，防止患者因病致贫、因病返贫。" 智通财经APP了解到，1月1日，《国家基本医疗保险、生育保险和工伤保险药品目录及商业健康保险创 新药品目录(2025年)》正式落地实施。在这份新目录中，科伦博泰生物-B(06990)自主研发的芦康沙妥珠 单抗(佳泰莱)、西妥昔单抗N01(达泰莱)与塔戈利单抗(科泰莱)三款创新药物成功跻身其中。 据悉，对于晚期三阴性乳腺癌患者及EGFR-TKI治疗失败的非小细胞肺癌患者而言，传统治疗手段往往 收效甚微。而作为科伦博泰自主研发的国内首个获完全批准上市的国产ADC(抗体药物偶联物)，芦康沙 妥珠单抗于2024年11月正式获批，用于治疗既往至少接受过2种系统治疗(其中至少1种针对晚期 ...