Core Viewpoint - The biotech sector, particularly companies involved in monoclonal antibody cancer therapies, experienced significant stock price volatility due to competitive developments, particularly the FDA approval of Akeso's cancer drug [1][2]. Group 1: Company Developments - Summit Therapeutics saw its shares drop by 36.1% following the news of Akeso's FDA approval, despite having positive phase 3 trial data for ivonescimab [1][5]. - BioNTech's shares fell by 15.4%, likely influenced by the competitive landscape as Akeso's drug received approval while BioNTech's drugs remain in late-stage trials [1][7]. - Akeso's penpulimab-kcqx received FDA approval for treating nasopharyngeal carcinoma, and ivonescimab was approved in China for PD-L1-positive non-small cell lung cancer [3][4]. Group 2: Competitive Landscape - Akeso's approval of its cancer drugs has created a competitive challenge for Summit, especially since Akeso holds rights to ivonescimab in China [4][5]. - The approval of Akeso's drugs may allow it to explore additional cancer treatments, potentially impacting Summit's market position [6]. - The rapid developments in the bispecific antibody space highlight the intense competition and uncertainty in the biotech industry, affecting investor sentiment towards companies like Summit and BioNTech [8].

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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC，其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司，在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成，包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...