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10月31日 | | --- | | 狀態: 新提交 | 致：香港交易及結算所有限公司 公司名稱: 福森藥業有限公司 呈交日期: 2025年11月3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) | 01652 | 說明 | 普通股 | | | | | | | | | | 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 | HKD | | 0.01 | HKD | | 20,000,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 2,000,000,000 | HKD | | 0.01 | HKD | | 20, ...

Market Overview - The A-share market experienced an overall decline on October 31, with major indices showing slight decreases. The Shanghai Composite Index fell by 0.63%, the Shenzhen Component Index decreased by 0.62%, and the ChiNext Index dropped by 1.49% [4][5]. Sector Performance - The media and biopharmaceutical sectors saw significant gains, with the media sector rising over 3% and individual stocks hitting the daily limit up. Notable stocks included Fushi Holdings and Rongxin Culture, both reaching the 20% limit up [5][6]. - The biopharmaceutical sector also performed well, with a nearly 2% increase and several stocks, including Sanofi and Lianhuan Pharmaceutical, hitting the daily limit up [5][7]. Notable Stocks - In the media sector, key stocks included: - Fushi Holdings: Current price 5.08, up 0.85, a rise of 20.09% - Rongxin Culture: Current price 39.60, up 6.60, a rise of 20.00% - Visual China: Current price 22.17, up 2.02, a rise of 10.02% [6]. - In the biopharmaceutical sector, notable stocks included: - Sanofi: Current price 72.96, up 12.16, a rise of 20.00% - Lianhuan Pharmaceutical: Current price 21.77, up 1.98, a rise of 10.01% [7]. Declining Stocks - Several previously popular stocks, such as Yizhongtian, experienced significant declines. For instance, Xinyi Sheng fell by 6.44%, and Tianfu Communication dropped by 7.76% after a previous decline of 11.56% [9]. Hong Kong Market - The Hong Kong market also saw a general decline, with the Hang Seng Index approaching the 26,000-point mark. Notable declines were observed in stocks like SMIC and BYD [11]. - However, Fosen Pharmaceutical experienced a surge, with its stock price increasing by over 80% after announcing the approval of its drug Enzalutamide soft capsules for prostate cancer treatment [10][12].

Market Overview - The Hang Seng Index fell by 0.89%, down 232 points, closing at 26,050 points, while the Hang Seng Tech Index dropped by 1.91% [1] - The early trading volume in the Hong Kong stock market reached HKD 142.3 billion [1] Biotechnology Sector - The Hang Seng Biotechnology Index rebounded by 2.16%, with notable gains in several stocks: - InnoCare Pharma (09606) surged by 10.88% - 3SBio (01530) increased by over 10% - Innovent Biologics rose by 6.82% - Kelun-Biotech (06990) gained 5.69% [1] - Fosen Pharmaceuticals (01652) saw a significant increase, with a peak rise of nearly 74% and an early gain of 59.42% following the approval of Enzalutamide soft capsules and the potential selection of Metformin and Empagliflozin for national procurement [1] - Rongchang Biopharma (09995) rose by 6.75%, reporting a 40% year-on-year revenue growth and a significant reduction in losses for the first three quarters [1] Medical Sector - Spring Medical (01858) increased by over 21%, turning a profit of HKD 77.06 million in the third quarter as the company actively expands its international market [2] New Stocks Performance - Newly listed Dipo Technology (01384) continued to rise, gaining 18.97% and doubling its stock price within three days of listing [3] Financial Sector - China Everbright Bank (06818) fell by 5% post-earnings, with both revenue and profit declining in the third quarter, facing pressure from fair value changes [4] Other Notable Stocks - Huahao Zhongtian Pharmaceutical-B (02563) experienced a significant drop of over 37% due to a large unlock of shares after one year of listing [5] - Lion Holdings (02562) plummeted over 24% to a new low, planning to issue convertible bonds to raise approximately HKD 260 million for investments in gold and related products [6] - Air China (00753) dropped over 8%, with a more than 11% decline in net profit for the third quarter, and plans to raise up to HKD 20 billion through A-share placement [7]

Group 1: Hong Kong Stock Market Updates - China Metallurgical Group (01618) saw a decline of over 5%, reporting a revenue of 335.09 billion yuan for the first three quarters, a year-on-year decrease of 18.79%, and a net profit of 3.97 billion yuan, down 41.88% [1] - Fosen Pharmaceutical (01652) surged nearly 74% after announcing that its subsidiary received approval for the "Enzalutamide Soft Capsule" from the National Medical Products Administration of China [1] - Sanhua Intelligent Control (02050) increased over 3%, with a revenue of 24.03 billion yuan for the first three quarters, a year-on-year growth of 16.86%, and a net profit of 3.24 billion yuan, up 40.85% [1] - Rongchang Biopharmaceutical (09995) rose over 5%, reporting a revenue of approximately 1.72 billion yuan, a year-on-year increase of 42.27%, and a net loss of about 551 million yuan, narrowing by 48.6% [1] - New Special Energy (01799) fell nearly 8%, with a revenue of 11.66 billion yuan and a net loss of 526 million yuan for the first three quarters [1] Group 2: Additional Hong Kong Stock Market Updates - Chuny Medical (01858) increased over 10%, reporting a revenue of 756 million yuan, a year-on-year growth of 48.75%, and a net profit of 192 million yuan, up 213.21% [2] - Innovent Biologics (01801) rose over 4%, achieving total product revenue exceeding 3.3 billion yuan in Q3, maintaining a strong year-on-year growth of about 40% [2] - Longpan Technology (02465) increased over 6%, with a revenue of approximately 5.83 billion yuan, a year-on-year growth of 2.91%, and a net loss of about 110 million yuan, narrowing by 63.53% [2] - 3SBio (01530) saw an early morning increase of nearly 7%, following a significant deal with Pfizer worth up to $12.5 billion [2] - China CNR Corporation (01766) fell over 8%, reporting a revenue of approximately 183.87 billion yuan, a year-on-year increase of 20.49%, and a net profit of about 9.96 billion yuan, up 37.53% [2] Group 3: US Stock Market Updates - Carvana (CVNA.US) dropped over 13%, reporting a Q3 revenue growth of 54.5% to $5.65 billion, exceeding analyst expectations [3] - Alphabet (GOOGL.US) rose nearly 2%, with Q3 revenue surpassing $100 billion, driven by strong AI demand boosting cloud business [3] - Meta Platforms (META.US) fell over 11%, reporting Q3 revenue of $51.2 billion, a 26% year-on-year increase, but net profit significantly below expectations due to a one-time tax expense [4] - Bitcoin-related stocks experienced declines, with Strategy (MSTR.US) down nearly 7% and Coinbase (COIN.US) down over 5% [4] - eBay (EBAY.US) plummeted 15%, marking its largest drop in over 20 years despite exceeding sales expectations [4] Group 4: Additional US Stock Market Updates - Comcast (CMCSA.US) fell 4%, losing 104,000 broadband users in Q3, marking the tenth consecutive quarter of user decline [5] - CoreWeave (CRWV.US) dropped over 6% after shareholders rejected a proposed acquisition [5] - Roblox (RBLX.US) fell over 15%, reporting Q3 revenue of $1.4 billion, a 48% year-on-year increase, but widening net losses [5] - Moderna (MRNA.US) rose over 13%, reportedly in talks for a large-scale acquisition with a major pharmaceutical company [6] - Altria (MO.US) fell over 7%, reporting adjusted EPS of $1.45, in line with market consensus, but net revenue declined by 1.7% [6]

Core Viewpoint - The innovative drug concept stocks experienced a significant rise on October 31, with multiple companies reaching notable gains in their stock prices [1]. Group 1: Stock Performance - Sangfor Health (三生国健) saw a 20% increase, reaching a price of 72.96 [2] - Shuyou Pharmaceutical (舒泰神) rose by 14.29%, with a current price of 36.47 [2] - TuoJing Life (透景生命) increased by 11.97%, priced at 24.78 [2] - Maiwei Biotechnology (迈威生物-U) gained 11.69%, now at 47.23 [2] - Zejing Pharmaceutical (泽璟制药-U) rose by 11.06%, with a price of 99.18 [2] - Rongchang Biotechnology (荣昌生物) increased by 10.87%, priced at 98.30 [2] - Other notable increases include Hite Biotechnology (海特生物) at 10.33% and Weili Chemical (微粒化工艺物) at 10.19% [2]. Group 2: Hong Kong Market Performance - In the Hong Kong market, Fosen Pharmaceutical (福森药业) surged by 53.62%, reaching a price of 1.060 [3] - Yingtu Biotechnology (映图生物-B) increased by 12.44%, priced at 318.200 [3] - Yaojie Ankang (药捷安康-B) rose by 9.45%, with a current price of 190.000 [3] - Other companies such as Xinda Biopharmaceutical (信达牛物) and Jinfang Pharmaceutical (劲方医药) also saw increases of 8.18% and 8.05%, respectively [3].

Core Viewpoint - The innovative drug concept stocks experienced a significant rally on October 31, with multiple stocks reaching their daily limit up or showing substantial gains, indicating a strong market sentiment towards the pharmaceutical sector [1]. Group 1: Stock Performance - Sangfor Health (三生国健) surged by 20% to a price of 72.96 [2] - Shuyou Shen (舒泰神) increased by 14.29% to 36.47 [2] - Tuo Jing Life (透景生命) rose by 11.97% to 24.78 [2] - Maiwei Biotechnology (迈威生物-U) gained 11.69% to 47.23 [2] - Zejing Pharmaceutical (泽璟制药-U) climbed 11.06% to 99.18 [2] - Rongchang Biopharmaceutical (荣昌生物) went up by 10.87% to 98.30 [2] - Other notable gainers included Haitai Biotechnology (海特生物) at +10.33% and Weiguan Biotechnology (微感生物) at +10.19% [2]. Group 2: Hong Kong Market Performance - Fosen Pharmaceutical (福森药业) saw a remarkable increase of 53.62% to 1.060 [3] - Yingtou Biotechnology (映图生物-B) rose by 12.44% to 318.200 [3] - Yaojie Jiankang (药捷家康-B) increased by 9.45% to 190.000 [3] - Other stocks such as Innovent Biologics (信达生物) and Jinfang Pharmaceutical (劲方医药) also experienced gains of 8.18% and 8.05% respectively [3].

Core Viewpoint - Fosun Pharma's stock surged nearly 74% during trading, currently up 49.28% at HKD 1.03, with a trading volume of HKD 10.37 million following the approval of its drug application by the National Medical Products Administration of China [1] Group 1: Drug Approvals - Fosun Pharma's wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., received approval for its "Enzalutamide Soft Capsule" for treating high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) and asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients after androgen deprivation therapy (ADT) failure [1] - The company also announced that its product, Metformin and Empagliflozin Tablets (I), is expected to win a bid in the recently published results of China's 11th national centralized drug procurement [1] Group 2: Recent Developments - In September, Fosun Pharma disclosed that its "Metformin and Empagliflozin Tablets (I)" received approval from the National Medical Products Administration of China for market launch [1]

Core Viewpoint - Fosun Pharma (01652) experienced a significant stock price increase, rising nearly 74% during trading, with a current increase of 49.28% to HKD 1.03, and a trading volume of HKD 10.37 million [1] Group 1: Product Approvals - The company's wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., received approval from the National Medical Products Administration of China for the listing application of "Enzalutamide Soft Capsules" [1] - The approved indications include treatment for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) in adult patients and asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients who have not received chemotherapy after androgen deprivation therapy (ADT) failure [1] Group 2: Other Product Developments - Fosun Pharma announced that its product Metformin and Ertugliflozin Tablets (I) has been proposed for winning the bid in the recently published results of the 11th batch of national centralized drug procurement in China [1] - The company previously announced in September that the listing application for "Metformin and Ertugliflozin Tablets (I)" has also been approved by the National Medical Products Administration of China [1]

Core Viewpoint - Fosun Pharma's subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration of China for the listing application of Enzalutamide soft capsules, which are indicated for the treatment of high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) and symptomatic or asymptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients who have failed androgen deprivation therapy (ADT) [1] Group 1 - Enzalutamide is an androgen receptor inhibitor that acts on the androgen receptor signaling pathway, competitively inhibiting the binding of androgens to androgen receptors, thereby suppressing androgen receptor nuclear translocation and the interaction between androgen receptors and DNA [1] - The primary metabolite of Enzalutamide, N-desmethyl-Enzalutamide, exhibits similar in vitro activity to Enzalutamide [1] - Enzalutamide has been shown to inhibit the proliferation of prostate cancer cells and induce apoptosis in vitro, and it can reduce tumor volume in mouse models of prostate cancer xenografts [1]

Core Viewpoint - Fosen Pharmaceutical's subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration of China for the listing application of Enzalutamide soft capsules, indicating a significant advancement in the treatment options for specific prostate cancer patients [1] Group 1: Product Approval - The approved indication for Enzalutamide includes treatment for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) in adult patients [1] - It is also approved for asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients who have failed androgen deprivation therapy (ADT) and have not received chemotherapy [1] Group 2: Mechanism of Action - Enzalutamide acts as an androgen receptor inhibitor, targeting the androgen receptor signaling pathway by competitively inhibiting the binding of androgens to the androgen receptor [1] - The drug suppresses androgen receptor nuclear translocation and the interaction between the androgen receptor and DNA [1] - The primary metabolite, N-desmethyl-Enzalutamide, exhibits similar in vitro activity to Enzalutamide [1] Group 3: Efficacy - In vitro studies show that Enzalutamide can inhibit the proliferation of prostate cancer cells and induce apoptosis in these cells [1] - In mouse models of prostate cancer xenografts, Enzalutamide has been shown to reduce tumor volume [1]