Core Viewpoint - The inclusion of the drug Pujihua® (Pralsetinib capsules, 100mg) in the latest National Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List by China's National Healthcare Security Administration is a significant development for the company, effective from January 1, 2026 [1] Company Summary - Pujihua® is an oral, once-daily targeted therapy medication [1]

Group 1 - The core point of the article is that Basestone Pharmaceuticals' drug, Pujihua (Pralsetinib), has been included in the latest National Medical Insurance Drug List in China, effective from January 1, 2026 [1] - Pujihua is an oral targeted therapy approved for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are RET gene fusion positive, as well as for certain thyroid cancer patients [1] - The drug has already been approved in Hong Kong and Taiwan for similar indications, demonstrating its regional market presence [1] Group 2 - The FDA has approved Pujihua under the brand name GAVRETO for specific indications related to metastatic RET fusion-positive NSCLC and thyroid cancer in adults and children aged 12 and above [2] - Pujihua was developed by Blueprint Medicines, which was acquired by Sanofi in July 2025, while Basestone Pharmaceuticals holds exclusive rights for its development and commercialization in Greater China [2] - In November 2023, Basestone Pharmaceuticals granted exclusive commercialization rights for Pujihua in mainland China to Shanghai Elios Pharmaceutical Technology Co., Ltd [2]

Group 1 - The core announcement is that Basilea Pharmaceutica's drug, Pralsetinib (brand name GAVRETO), has been included in China's National Medical Insurance catalog, effective January 1, 2026 [1] - Pralsetinib is an oral targeted therapy approved for treating adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and other specific thyroid cancers [1][2] - The drug has already received approval in Hong Kong and Taiwan for similar indications, expanding its market presence in Greater China [1] Group 2 - The FDA has approved GAVRETO for the treatment of adult patients with metastatic RET fusion-positive NSCLC and certain thyroid cancers, indicating its acceptance in the U.S. market [2] - Basilea Pharmaceutica holds exclusive development and commercialization rights for Pralsetinib in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan [2] - In November 2023, Basilea Pharmaceutica granted exclusive commercialization rights for Pralsetinib in mainland China to Shanghai Elios Pharmaceutical Technology Co., Ltd [2]

Core Viewpoint - The inclusion of the drug Praluent® (Pralsetinib capsules, 100 mg) in China's National Medical Insurance Catalog is a significant development for the company, as it will officially take effect on January 1, 2026, enhancing the drug's market access and potential sales in the region [1]. Group 1: Drug Approval and Indications - Praluent® is an oral targeted therapy approved by the National Medical Products Administration (NMPA) for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are RET gene fusion positive, as well as for adult and pediatric patients aged 12 and above with advanced or metastatic RET mutation medullary thyroid carcinoma (MTC) requiring systemic treatment [1][2]. - The drug has also been approved in Hong Kong for treating adult patients with metastatic RET fusion-positive NSCLC and in Taiwan for similar indications, including advanced or metastatic RET fusion-positive thyroid cancer [1]. Group 2: Commercialization and Partnerships - The drug Praluent® was developed by Blueprint Medicines, which was acquired by Sanofi in July 2025, indicating a strategic partnership that may enhance the drug's development and commercialization efforts [2]. - The company has granted exclusive commercialization rights for Praluent® in mainland China to Shanghai Elios Pharmaceutical Technology Co., Ltd. as of November 2023, which may streamline marketing and distribution efforts in the region [2].

Core Viewpoint - Company 基石药业-B (02616.HK) announced that its drug 普吉华® (Pralsetinib capsules, 100 mg) has been included in the latest National Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List published by China's National Healthcare Security Administration, which will take effect on January 1, 2026 [1] Group 1 - 普吉华® is an oral targeted therapy taken once daily [1] - The drug has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are RET gene fusion positive, as well as for adult and pediatric patients aged 12 and above with RET mutation medullary thyroid carcinoma (MTC) requiring systemic treatment [1] - The drug is also indicated for adult and pediatric patients aged 12 and above with advanced or metastatic RET fusion positive thyroid cancer requiring systemic treatment and who are refractory to radioactive iodine treatment, if applicable [1] Group 2 - 普吉华® has already been approved in Hong Kong for the treatment of adult patients with metastatic NSCLC who are RET gene fusion positive [1] - In Taiwan, the drug has been approved for the treatment of locally advanced or metastatic RET fusion positive NSCLC, advanced or metastatic RET mutation MTC requiring systemic treatment, and advanced or metastatic RET fusion positive thyroid cancer in adults requiring systemic treatment and refractory to radioactive iodine treatment [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 ( 於開曼群島註冊成立的有限公司 ) (股份代號：2616) 自願 公告 基石藥業宣佈普吉華®（普拉替尼膠囊）納入2025年國家醫保目錄 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 ...

本月底法定/註冊股本總額： USD 200,000 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年11月30日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 基石藥業 | | | | | | 呈交日期: | 2025年12月4日 | | | | | | I. 法定/註冊股本變動 | | | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 (註1) | 是 | | 證券代號 (如上市) | 02616 | 說明 | | | | FF301 第 1 頁 共 10 頁 v 1.1.1 法定/註冊股份數目 面值 法定/註冊股本 上月底結存 2,000,000,000 USD 0.0001 USD 200,000 增加 / 減少 (-) 0 USD 0 本月底結存 2,000,000,000 USD 0.0001 USD 200,000 FF301 II. 已發行股份及/ ...

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] Company Summary - 基石药业-B (02616) experienced a stock price increase of nearly 7% during trading, closing up 5.22% at HKD 6.25, with a trading volume of HKD 39.03 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 first-line treatment of metastatic squamous and non-squamous NSCLC, indicating comprehensive coverage from stage III to IV NSCLC in Europe [1] Industry Summary - The approval signifies a broader treatment landscape for NSCLC patients in Europe, enhancing the accessibility of Sugli monoclonal antibody globally [1]

Core Viewpoint - 基石药业's stock price increased nearly 7%, currently trading at 6.23 HKD, following the European Commission's approval of a new indication for Shugli monoclonal antibody in treating specific non-small cell lung cancer (NSCLC) patients [1] Group 1: Company Developments - The European Commission has approved Shugli monoclonal antibody for monotherapy in 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] - Dr. Yang Jianxin, CEO and R&D President of 基石药业, stated that this new indication approval marks a significant milestone, providing comprehensive treatment options for a broader patient population in Europe, following the initial approval for first-line treatment of metastatic squamous and non-squamous NSCLC in 2024 [1] - The company aims to enhance the accessibility of Shugli monoclonal antibody globally, reaffirming its long-term commitment to patients [1]

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].