Market Overview - The Hang Seng Index increased by 0.46%, gaining 119 points to reach 26,013 points, while the Hang Seng Tech Index rose by 0.51%. The morning trading volume in Hong Kong was HKD 114 billion [1]. Airline Sector - Airline stocks led the gains, with China Eastern Airlines (00670) rising over 6% due to improved oil cost dynamics benefiting airline performance [2]. Biotechnology Sector - The Hang Seng Biotechnology Index rose over 2%. Rongchang Biopharmaceutical (09995) increased by over 5%, and Kangfang Biotech (09926) rose over 4%. China Biopharmaceutical (01177) gained 2.59% following significant breakthroughs in its self-developed HER2 dual-target ADC for breast cancer. Junshi Biosciences (01877) also saw an increase of over 3% as its Toripalimab subcutaneous injection Phase III clinical trial met its primary endpoint, with plans for subsequent listing application [3]. Pharmaceutical Sector - Basilea Pharmaceutica (02616) rose over 6% after the European Commission approved a new indication for Sugliquide [4]. AI and Technology Sector - GDS Holdings (09698) increased nearly 4% as domestic AI chip supply improved, with Morgan Stanley projecting a surge in orders by the second half of next year [5]. - Changfei Optical Fiber (06869) rose nearly 7% due to increased interest in Google's TPU chips, with institutions optimistic about AI-driven growth. Smoore International (06969) gained over 4% after signing a long-term battery cell procurement agreement with EVE Energy to secure supply for its electronic cigarette products [6]. E-commerce Sector - Alibaba Group (09988) saw a decline of over 2% during trading, with its adjusted net profit for the second fiscal quarter dropping 72% year-on-year [7].

Core Viewpoint - 基石药业-B (02616.HK) experienced a significant increase in stock price, rising over 5% to reach 5.94 HKD with a trading volume of 8.2294 million HKD [1] Group 1 - The stock price of 基石药业-B increased by 5.32% [1] - The current trading price is 5.94 HKD [1] - The total trading volume reached 822.94 million HKD [1]

Core Viewpoint - The European Commission has approved a new indication for Sugli monoclonal antibody, expanding its treatment options for adult patients with advanced non-small cell lung cancer (NSCLC) [1] Company Summary - 基石药业-B's stock price increased by 4.61% to 5.90 HKD with a trading volume of 12.15 million HKD [1] - The approval allows Sugli to be used as a monotherapy for adult patients with unresectable stage III NSCLC who have PD-L1 expression ≥1%, no EGFR sensitive mutations, or ALK/ROS1 genomic alterations, and have not shown disease progression after platinum-based chemoradiotherapy [1] - The CEO, Dr. Yang Jianxin, highlighted that this new indication approval marks a significant milestone, providing comprehensive treatment coverage from stage III to IV NSCLC in Europe within just one year of the initial approval for metastatic NSCLC [1]

Core Viewpoint - The approval of a new indication for Sugli monoclonal antibody by the European Commission marks a significant advancement for the company, providing new treatment options for a broader patient population with advanced non-small cell lung cancer (NSCLC) [1] Group 1: Company Developments - Company shares of 基石药业-B (02616) rose by 5.32%, reaching HKD 5.94, with a trading volume of HKD 8.2294 million [1] - The European Commission has approved Sugli monoclonal antibody for the treatment of adult patients with inoperable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1%, no EGFR sensitive mutations or ALK, ROS1 genomic alterations, and have not experienced disease progression after platinum-based chemoradiotherapy [1] - The CEO of the company, Dr. Yang Jianxin, highlighted that this new indication approval comes just one year after the initial approval for first-line treatment of metastatic squamous and non-squamous NSCLC, indicating comprehensive coverage from stage III to IV NSCLC in Europe [1]

Core Viewpoint - The approval of a new indication for Sugli monoclonal antibody by the European Commission marks a significant advancement for the company, providing new treatment options for a broader patient population with advanced non-small cell lung cancer (NSCLC) [1] Group 1: Company Developments - 基石药业-B (02616) shares rose over 5%, specifically by 5.32%, reaching HKD 5.94 with a trading volume of HKD 8.2294 million [1] - The European Commission has approved Sugli monoclonal antibody for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1%, no EGFR sensitive mutations or ALK, ROS1 genomic alterations, and have not shown disease progression after platinum-based chemoradiotherapy [1] - The CEO of the company, Dr. Yang Jianxin, highlighted that this new indication approval comes just one year after the initial approval for Sugli monoclonal antibody for first-line treatment of metastatic squamous and non-squamous NSCLC, indicating comprehensive coverage from stage III to IV NSCLC in Europe [1]

Group 1 - Novo Nordisk's clinical trials for semaglutide in Alzheimer's disease failed to meet primary endpoints, leading to a significant drop in the company's stock price [1] - The failure highlights the high failure rate of drug development in the Alzheimer's field, although there is increasing enthusiasm from Chinese pharmaceutical companies in this area [1] Group 2 - CStone Pharmaceuticals announced that the European Commission has approved a new indication for sugemalimab, allowing its use as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) [2] - This approval makes sugemalimab the second PD-(L)1 antibody for stage III NSCLC in Europe, addressing a critical treatment need and marking full disease course coverage from stage III to IV [2] Group 3 - Two biotech companies, Kew Med and Mingyu Pharmaceutical, submitted applications for IPOs on the Hong Kong Stock Exchange, both of which are in clinical stages without any approved products [3] - The trend reflects the attractiveness of the Hong Kong market for biopharmaceutical companies, although investors are advised to remain rational and monitor the companies' R&D progress and potential risks [3] Group 4 - Innovent Biologics announced that its high-dose 9mg injection of mazhitide for long-term weight control in adults with moderate to severe obesity has been accepted for review by the NMPA [4] - This product may provide a new treatment option for the domestic population suffering from obesity, but the competitive landscape in the weight loss drug market introduces uncertainty regarding its sales performance [4]

Group 1 - Novo Nordisk's clinical trials for semaglutide in Alzheimer's disease failed to meet primary endpoints, leading to a significant drop in the company's stock price [1] - The failure highlights the high failure rate of drug development in the Alzheimer's disease sector, which remains poorly understood [1] - Despite setbacks in this area, Chinese pharmaceutical companies are increasingly enthusiastic about research and development, potentially offering new hope for patients [1] Group 2 - CStone Pharmaceuticals announced that the European Commission has approved a new indication for sugemalimab, allowing its use as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) [2] - This approval makes sugemalimab the second PD-(L)1 antibody approved for stage III NSCLC in Europe, addressing a critical treatment need in this disease area [2] - The approval signifies comprehensive coverage of the treatment journey for NSCLC from stage III to IV for sugemalimab in Europe [2] Group 3 - Two biotech companies, Kew Med and Mingyu Pharmaceutical, submitted applications for IPOs on the Hong Kong Stock Exchange, both of which are in the clinical stage without any approved products [3] - The trend of biotech companies seeking funding through the Hong Kong market indicates its growing attractiveness for the sector [3] - Investors are advised to remain rational and monitor the companies' research progress and potential risks, avoiding blind speculation [3] Group 4 - Innovent Biologics announced that its high-dose 9mg injection of mazdutide for long-term weight control in adults with moderate to severe obesity has been accepted for review by the NMPA [4] - Mazdutide is expected to provide a new treatment option for the domestic population struggling with obesity, beyond surgical interventions [4] - The competitive landscape for weight loss medications is intensifying, leading to uncertainty regarding the product's sales performance, necessitating a cautious approach from investors [4]

Group 1 - The European Commission (EC) has approved a new indication for Sugli monoclonal antibody for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1%, no EGFR sensitive mutations, or ALK, ROS1 genomic alterations, and have not shown disease progression after platinum-based chemoradiotherapy (CRT) [1][2] - This approval marks Sugli as the second PD-(L)1 antibody approved for stage III NSCLC in Europe, addressing a critical treatment need in this disease area [1][2] - The approval comes just one year after the EC's initial approval of Sugli for first-line treatment of metastatic squamous and non-squamous NSCLC, indicating a rapid progression in the drug's availability for a broader patient population [1] Group 2 - The company emphasizes its commitment to enhancing global access to Sugli, ensuring that innovative treatments reach patients worldwide [1] - The clinical development and registration team of the company is recognized for their efficient execution, which facilitated the swift approval of Sugli under the European Medicines Agency (EMA) review pathway [1]

Core Viewpoint - The European Commission has approved a new indication for Sugrilimab, allowing its use as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1%, no EGFR sensitive mutations or ALK/ROS1 genomic alterations, and have not experienced disease progression after platinum-based chemoradiotherapy [1] Company Summary - 基石药业's CEO, Dr. Yang Jianxin, highlighted that this new indication approval comes just one year after the first approval for Sugrilimab in the first-line treatment of metastatic squamous and non-squamous NSCLC, marking comprehensive coverage from stage III to IV NSCLC in Europe [1] - The company aims to enhance the accessibility of Sugrilimab globally, reaffirming its long-term commitment to patients [1] Industry Summary - The approval of Sugrilimab as the second PD-(L)1 antibody for stage III NSCLC in Europe addresses a critical treatment need in this disease area [1] - The efficient execution of the clinical development and registration team at 基石药业 has ensured a swift and smooth approval process under the European Medicines Agency (EMA) review pathway [1]

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。 本公告所作出的前瞻性陳述僅與本文作出該陳述當日的事件或資料有關。除法律規定外，於作出前 瞻性陳述當日之後，無論是否出現新資料、未來事件或其他情況，我們並無責任更新或公開修改任 何前瞻性陳述及預料之外的事件。請細閱本公告，並理解我們的實際未來業績或表現可能與預期有 重大差異。本公告中有關我們或任何董事及╱或本公司的意向的陳述或提述乃於本公告刊發日期作 出。任何該等意向均可能因未來發展而出現變動。 CStonePharmaceuticals 基石藥業 (股份代號：2616) 自願 公告 舒格利單抗獲歐盟委員會批准用於治療Ⅲ期非小細胞肺癌 本公告乃由基石藥業(「本公司」連同其附屬公司統稱「本集團」或「基石藥業」)自願作出， 以使本公司股東及潛在投資者瞭解本集團的最新業務發展。 …………………………………………………………………………………………… 基石藥業今日宣佈歐盟委員會（EC）已批准舒格利單抗的新適應症： ...