Core Viewpoint - The company Kolon Biotech announced that the final analysis results of the overall survival (OS) from the OptiTROP-Lung03 clinical study of its antibody-drug conjugate (ADC) sac-TMT will be presented at the 2026 European Lung Cancer Conference (ELCC) in Copenhagen from March 25 to 28, 2026, with the study's abstract published in ESMO Open [1] Group 1 - The OptiTROP-Lung03 study aims to evaluate the efficacy and safety of sac-TMT monotherapy (5 mg/kg every two weeks) compared to docetaxel in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) who have previously received EGFR-TKI and platinum-based chemotherapy [2] - Results presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting showed that among 137 randomized patients, sac-TMT demonstrated significant statistical and clinical improvements in progression-free survival (PFS) and OS compared to docetaxel, with a PFS hazard ratio (HR) of 0.30 (95% CI: 0.20–0.46, one-sided p<0.001) and an OS HR of 0.49 (95% CI: 0.27–0.88, one-sided p=0.007) [2] - Based on these positive results, sac-TMT received approval from the National Medical Products Administration (NMPA) for this indication, which has been included in the national medical insurance catalog [2] Group 2 - The 2026 ELCC will present the final analysis results of the OS from the OptiTROP-Lung03 study, along with updated PFS data, with a median follow-up time of 23.8 months as of December 11, 2025 [3] - In the docetaxel treatment control group, 41.3% of patients chose to receive subsequent sac-TMT treatment after disease progression. The median OS for the sac-TMT group was 20.0 months compared to 11.2 months for the docetaxel group (HR 0.45, 95% CI: 0.28–0.73), with 18-month OS rates of 54.7% vs 9.1% [3] - If the OS of the control group is not adjusted for subsequent sac-TMT treatment, the median OS for the two groups would be 20.0 months vs 13.5 months (HR 0.63, 95% CI: 0.40–0.98). The investigator-assessed median PFS was 7.9 months vs 2.8 months (HR 0.23, 95% CI: 0.15–0.35) [3]

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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致之任何損失承擔任何責任。 Keymed Biosciences Inc. 康諾亞生物醫藥科技有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2162） 自願性公告 與AstraZeneca就核心產品 CMG901 (AZD0901)的合作更新 本公告乃由康諾亞生物醫藥科技有限公司（「本公司」，連同其附屬公司「本集團」） 董事會（「董事會」）謹此向其股東及潛在投資者提供有關本集團與AstraZeneca AB（「AstraZeneca」，一家全球生物製藥公司）就核心產品CMG901（sonesitatug vedotin，亦稱為AZD0901）合作的最新情況。 於2023年2月，KYM Biosciences Inc.（「KYM」，為本集團擁有70%權益的非全資 附屬公司）與AstraZeneca已訂立全球獨家許可協議（「許可協議」），以開發及商業 化CMG901，CMG901為本集團與Innocube Limited（由樂 ...

Core Viewpoint - Fudan Zhangjiang has reported significant advancements in its R&D investments and clinical trials, particularly in the fields of antibody-drug conjugates (ADC) and photodynamic therapy drugs, indicating a strong potential for future growth and product diversification [1][2] Group 1: R&D Investments - The company invested approximately 358 million RMB in R&D during the reporting period, with a steady increase in the proportion of R&D spending relative to revenue [1] - R&D funding is primarily directed towards ADC and photodynamic drug development, with multiple pipelines achieving key progress [1] Group 2: ADC Developments - The Phase III clinical trial for the FDA018 ADC targeting triple-negative breast cancer has exceeded its enrollment target, with over 350 participants, and data collection is currently underway [1] - The Phase II clinical study for the FDA022 ADC, aimed at HER2 low-expressing breast cancer, has completed patient enrollment and successfully held a communication meeting with regulatory authorities [1] Group 3: Photodynamic Therapy Developments - The application for marketing authorization of the oral solution of aminolevulinic acid for intraoperative visualization in high-grade glioma has been accepted, which could enhance the company's product portfolio and core competitiveness in the photodynamic therapy sector [1] Group 4: Industrialization Support - Fudan Zhangjiang's wholly-owned subsidiary, Taizhou Fudan Zhangjiang, is providing support for the industrialization of its ADC projects, including technology transfer and production process validation [2] - The commercialization of related products is expected to create new growth points for the company, contributing to its long-term high-quality development [2]

Core Viewpoint - The company, Immune-Onc Therapeutics, is set to present the latest efficacy and safety results of its investigational B7H3 antibody-drug conjugate, DB-1311/BNT324, for treating previously treated metastatic castration-resistant prostate cancer (mCRPC) patients at the 2026 ASCO GU Cancer Symposium [1]. Group 1: Study Overview - The 1/2 phase study (NCT05914116) involves a dose-optimization cohort where mCRPC patients previously treated received DB-1311/BNT324 at doses of 6 mg/kg or 9 mg/kg every three weeks [1]. - In the dose-expansion cohort, patients who had received Lu 177 treatment and those who had not received taxane therapy were administered 6 mg/kg every three weeks until disease progression or intolerable toxicity occurred [1]. Group 2: Patient Demographics and Treatment Outcomes - As of September 5, 2025, 104 mCRPC patients had received DB-1311/BNT324 treatment, with a median follow-up of 9.2 months; 50% of patients remained on treatment [2]. - The median age of patients was 70 years, with a majority being white (53%), followed by Asian (31%) and Black (13%); the median number of prior treatments was 4 [2]. - Among 58 patients eligible for tumor response assessment, the unconfirmed objective response rate was 41.4%, and the confirmed objective response rate was 34.5%, with a disease control rate of 87.9% [2]. Group 3: Progression-Free Survival and Overall Survival - In 82 patients evaluable for radiographic progression-free survival (rPFS), the median rPFS was 11.3 months, with 6-month and 9-month rPFS rates of 72.0% and 63.0%, respectively [2]. - Overall survival (OS) data was not yet mature, but the 6-month and 9-month OS rates were reported at 91.7% and 88.2% [3]. Group 4: Safety Profile - The safety profile was consistent with previous reports, with the most common adverse events being nausea and hematological events, primarily grade 1-2 [3]. - Among the 104 patients, 34 (33%) had previously received Lu 177 treatment, with similar outcomes observed between those who had and had not received Lu 177, although the PSA duration of response was shorter in the former group [3].

中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團全 資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的國家1類創新藥維特柯妥拜單抗（研 發代號：LM-302）「CLDN18.2 ADC」正在開展用於治療三線及以上CLDN18.2陽性的局部晚期或轉移 性胃及胃食管交界部腺癌的III期註冊臨床試驗(LM302-03-101)，已順利完成患者入組。其中，LM- 302是全球首款完成註冊III期臨床試驗入組的CLDN18.2 ADC藥物。 LM-302是一款靶向CLDN18.2的抗體偶聯藥物(ADC)，通過與CLDN18.2陽性腫瘤細胞特異性結合， 並經內吞作用進入細胞後釋放小分子毒素，從而實現對腫瘤細胞的精準殺傷。作為潛在同類首創 (FIC)藥物，LM-302在胃癌、胰腺癌及膽道癌等多個消化道腫瘤中展現出良好的臨床開發潛力，並有 望為CLDN18.2低表達和PD-L1低表達患者提供新的治療選擇。 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 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the fourth indication of its core product, TROP2 ADC, sac-TMT, for the treatment of 2L+ HR+/HER2- breast cancer [2][6]. Drug Basic Information - The approval is based on positive results from the OptiTROP-Breast02 Phase III clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) Congress [2][3]. - The new indication is for adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [2][3]. Clinical Study Results - The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT compared to investigator's choice of chemotherapy in patients with HR+/HER2- breast cancer [3]. - Among enrolled patients, 95.7% had visceral metastases, and 75.9% had liver metastases [3]. - The study showed a significant improvement in progression-free survival (PFS) for the sac-TMT group compared to the chemotherapy group (8.3 months vs. 4.1 months; hazard ratio (HR): 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [3]. - The overall survival (OS) benefit trend and objective response rate (ORR) were also significantly higher in the sac-TMT group (41.5% vs. 24.1%) [3]. Product Overview - Sac-TMT is a novel TROP2 ADC developed by Kelun Botai, targeting various advanced solid tumors, including non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), and gynecological tumors [5]. - The drug utilizes a new linker and has a drug-antibody ratio (DAR) of 7.4, delivering a topoisomerase I inhibitor as an effective payload [5]. - Sac-TMT has received six breakthrough therapy designations (BTD) from the NMPA [6]. Ongoing Research - Currently, sac-TMT is involved in nine registration clinical studies in China, with Merck conducting 16 ongoing global Phase III clinical studies for various cancer types [7].

Group 1 - The core product of the company, the TROP2-targeted antibody-drug conjugate (ADC) sac-TMT, has received approval from the National Medical Products Administration (NMPA) in China for its fourth indication, aimed at treating adult patients with HR+/HER2- breast cancer who have previously undergone endocrine therapy and at least one line of chemotherapy in the advanced disease stage [1][2] - The approval is based on positive results from the OptiTROP-Breast02 Phase 3 clinical study, which has been selected for a breakthrough abstract presentation at the 2025 European Society for Medical Oncology (ESMO) conference [1] Group 2 - The company has renewed a framework agreement with China Resources Kolun for research and development-related materials, extending until 2026 [2]

Core Viewpoint - The approval of the antibody-drug conjugate sac-TMT (also known as SKB264/MK-2870) for a new indication in treating HR+/HER2- breast cancer in China represents a significant advancement for the company and the industry, particularly for patients who have undergone prior endocrine therapy and at least one line of chemotherapy [1] Group 1: Regulatory Approval - The National Medical Products Administration (NMPA) of China has approved sac-TMT for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [1] - This approval marks the fourth indication for sac-TMT in China [1] Group 2: Clinical Study Results - The approval is based on positive results from the OptiTROP-Breast023 phase II clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] - The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT compared to physician's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- breast cancer, with 95.7% of patients having visceral metastases and 75.9% having liver metastases at enrollment [2] - The study showed a significant improvement in progression-free survival (PFS) for the sac-TMT group compared to the chemotherapy group (8.3 months vs. 4.1 months; hazard ratio (HR), 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [2] - Consistent PFS benefits were observed across predefined subgroups, including those with HER2 expression of 0 and low expression [2] - The overall survival (OS) benefit trend and objective response rate (ORR) were also significantly higher in the sac-TMT group (41.5% vs. 24.1%) [2] Group 3: Ongoing Research - Ongoing phase III clinical studies are evaluating sac-TMT, with or without pembrolizumab, for treating HR+/HER2- breast cancer patients who have previously received endocrine therapy but not chemotherapy, both globally and in China [3]

Core Viewpoint - The approval of the antibody-drug conjugate sac-TMT (also known as SKB264/MK-2870) for a new indication in treating HR+/HER2- breast cancer patients in China marks a significant milestone for the company, expanding its therapeutic applications in oncology [1] Group 1: Regulatory Approval - The National Medical Products Administration (NMPA) of China has approved sac-TMT for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [1] - This approval represents the fourth indication for sac-TMT in China [1] Group 2: Clinical Study Results - The approval is based on positive results from the OptiTROP-Breast023 phase II clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] - The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT compared to investigator-selected chemotherapy in patients with unresectable or metastatic HR+/HER2- breast cancer, with 95.7% of patients having visceral metastases and 75.9% having liver metastases at enrollment [2] - The study showed a significant improvement in progression-free survival (PFS) for the sac-TMT group compared to the chemotherapy group (8.3 months vs. 4.1 months; hazard ratio (HR), 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [2] - Consistent PFS benefits were observed across predefined subgroups, including those with different HER2 expression levels and prior chemotherapy lines [2] - The overall survival (OS) benefit trend and objective response rate (ORR) were also significantly improved in the sac-TMT group (41.5% vs. 24.1%) [2] Group 3: Ongoing Research - Ongoing phase III clinical studies are investigating sac-TMT, with or without pembrolizumab, for HR+/HER2- breast cancer patients who have previously received endocrine therapy but not chemotherapy, both globally and in China [3]

Core Insights - The company achieved total product revenue of approximately RMB 11.9 billion in 2025, marking a strong year-on-year growth of about 45% [1] - In Q4 2025, the company recorded total product revenue of approximately RMB 3.3 billion, with a year-on-year increase of over 60%, driven by the inclusion of six new drugs in the 2026 National Medical Insurance Directory [1] Group 1 - 2025 marked a milestone year for the company as product revenue surpassed RMB 10 billion, reflecting the successful implementation of its "dual-driven and global innovation" strategy [2] - The company has strengthened its leading position in the oncology treatment sector, expanding its oncology product portfolio to 13 products, with core products like Darbeshou (Sintilimab injection) showing steady growth [2] - The company has successfully ventured into the chronic disease commercialization field, leveraging unmet needs and strong product competitiveness to drive growth, with key products like Xin'ermei (Masitide injection) and Xinbile (Torecilizumab injection) becoming significant revenue contributors [2] Group 2 - The company's global innovation strategy continues to make breakthroughs, focusing on next-generation immunotherapy (IO) and antibody-drug conjugates (ADC) in oncology, as well as innovations in metabolism, cardiovascular, autoimmune, and ophthalmology fields [3] - The company aims to become an internationally leading biopharmaceutical company, supported by its ongoing clinical development and strategic advantages in flexible layout and efficient execution [3]