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 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 本公司董事會（「董事會」）欣然宣佈，近日，本集團收到美國食品藥品管理 局（「FDA」）的批准函，POHERDY® （帕妥珠單抗）420mg/14mL(30mg/mL)注 射液（供靜脈注射使用）的生物製品許可申請(BLA)獲FDA批准，該商品名 由N.V.Organon於美國註冊商標。本次獲批適應症為：(1)與曲妥珠單抗和多 西他賽聯合，用於治療既往未接受過針對轉移性疾病抗HER2治療或化療的 HER2陽性、轉移性乳腺癌(MBC)成人患者；(2)與曲妥珠單抗和化療聯合， 作為：(i)早期乳腺癌整體治療方案的一部分，用於HER2陽性、局部晚期、 炎性或早期乳腺癌成人患者（直徑＞2cm或淋巴結陽性）的新輔助治療；及(ii) 用於具有高複發風險的HER2陽性早期乳腺癌成人患者 ...

Group 1 - Tsugami Machine Tool China (01651) saw a rise of over 5.4% due to increased demand for high-precision machine tools in emerging sectors like new energy vehicles and artificial intelligence as China's economy gradually recovers [1] - Black Sesame Intelligence (02533) increased by over 2.2% after announcing that its flagship product, the Huashan A1000 automotive-grade high-performance driving assistance chip, has been successfully integrated into Desay SV's new low-speed unmanned vehicle brand "Chuanxing Zhiyuan" S6 series [1] - Zai Xin Bio-B (02509) rose over 5.8% after receiving clinical trial approval for its self-developed long-acting dual antibody QX027N injection, intended for the treatment of asthma and atopic dermatitis [1] - CanSino Biologics (06185) increased nearly 5% as it announced the initiation of Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia [1] Group 2 - Kingsray Biotechnology (01548) rebounded over 4.48% following the financial performance disclosure of its joint venture Legend Biotech for the third quarter ending September 30, 2025 [2] - Fuhong Hanlin (02696) rose over 5.2% after its PD-1 antibody drug, Surufilumab injection, was proposed for breakthrough therapy designation for use in combination with chemotherapy for gastric cancer [2] - Yidu International Holdings (00259) increased over 6% amid uncertainty regarding the impact of an undisclosed event on its financial statements for the year ending March 31, 2025 [2] Group 3 - Reshaping Energy (02570) surged nearly 60%, with a rise of 55.03%, following announcements from the National Energy Administration encouraging the use of green hydrogen in coal chemical projects and plans to promote over 2,000 hydrogen vehicles in Shandong Province [3] - Laika Pharmaceuticals-B (02105) saw a reverse increase of over 10.3% after granting Qilu Pharmaceutical exclusive rights for research, development, and commercialization of the breast cancer candidate drug LAE002 (afuresertib) in China [3] Group 4 - WMCH GLOBAL (08208) resumed trading with a rise of over 50%, increasing by 57.45% after announcing the sale of approximately 384 million shares, representing about 53.297% of its issued share capital [4] Group 5 - U.S. stock market opened lower, with the Nasdaq dropping 2.04%, as major tech stocks like Nvidia, AMD, and Tesla saw declines [5] - Tencent reached an agreement with Apple regarding payment processing for WeChat mini-games, potentially opening new revenue streams for Apple [5] - Mangoceuticals (MGRX.US) plummeted 32.39% after announcing partnerships with Eli Lilly and Novo Nordisk to provide users with weight loss medications [6] - Fannie Mae (FNMA.US) fell 9.82%, with a two-day cumulative drop of 20%, amid investigations into the actions of the Federal Housing Finance Agency director [6] - Disney (DIS.US) dropped 7.75% despite strong performance in streaming and theme parks, as upcoming major film releases are expected to impact first-quarter performance [6]

每经AI快讯，复宏汉霖(02696.HK)再涨超5%，截至发稿，涨6.02%，报68.7港元，成交额3425.31万港 元。 ...

Core Viewpoint - Fuhong Hanlin (02696) shares have increased by over 5%, currently up 6.02% at HKD 68.7, with a trading volume of HKD 34.25 million [1] Group 1: Company Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulitinib injection (H drug), is proposed to be included as a breakthrough therapy for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, marking its first recognition for this status [1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally [1] Group 2: Investment Activity - On November 6 and November 10, Boyu Capital purchased 262,500 shares and 80,000 shares of Fuhong Hanlin's H shares, increasing their holdings from 5.84% to 7% [1] - Earlier, on June 18, Boyu Capital had invested HKD 21.27 million to increase their stake from 4.89% to 5.15%, surpassing the 5% threshold for mandatory disclosure [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 5%, reaching a price of 68.7 HKD, with a trading volume of 34.25 million HKD, following the announcement of its PD-1 antibody drug, Surulitinib injection (H drug), being proposed for breakthrough therapy designation for use in combination with chemotherapy for gastric cancer [1] Group 1: Company Developments - The H drug is the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally [1] - On November 6 and November 10, Boyu Capital increased its holdings in Fuhong Hanlin by purchasing 262,500 shares and 80,000 shares of H shares, raising its stake from 5.84% to 7% [1] - Boyu Capital had previously invested 21.27 million HKD to increase its holdings from 4.89% to 5.15% on June 18, crossing the 5% threshold for mandatory disclosure [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the approval of two biosimilars, BILDYOS and BILPREVDA, by the UK Medicines and Healthcare products Regulatory Agency, covering all indications of the original drugs in the UK [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.53%, reaching 64.6 HKD, with a trading volume of 79.4842 million HKD [1] - The UK regulatory approval allows Fuhong Hanlin to commercialize BILDYOS and BILPREVDA, which are part of a broader agreement with Organon for exclusive commercialization rights outside of China [1] - Boyu Capital has increased its stake in Fuhong Hanlin, acquiring 262,500 shares and 80,000 shares on November 6 and November 10, respectively, raising its holding from 5.84% to 7% [1] Group 2: Financial Transactions - Boyu Capital previously invested 21.2673 million HKD to increase its stake from 4.89% to 5.15% on June 18, crossing the 5% threshold for reporting [1]

Core Viewpoint - Fuhong Hanlin (02696) shares have risen over 4% following the approval of two biosimilars, BILDYOS and BILPREVDA, by the UK Medicines and Healthcare products Regulatory Agency [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 4.53%, reaching 64.6 HKD, with a trading volume of 79.4842 million HKD [1] - The UK regulatory approval covers all indications for the original drugs [1] - In 2022, Fuhong Hanlin granted Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [1] Group 2: Investment Activity - Boyu Capital Investment Management Limited purchased 262,500 shares and 80,000 shares of Fuhong Hanlin on November 6 and November 10, respectively, increasing their stake from 5.84% to 7% [1] - Earlier, on June 18, Boyu Capital had invested 21.2673 million HKD to raise their stake from 4.89% to 5.15%, surpassing the 5% threshold for reporting [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the approval of its biosimilars BILDYOS and BILPREVDA by the UK Medicines and Healthcare products Regulatory Agency, which now cover all indications previously approved for the original drugs in the UK [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.53%, reaching HKD 64.6, with a trading volume of HKD 79.4842 million [1] - The UK regulatory approval allows Fuhong Hanlin to commercialize BILDYOS and BILPREVDA, which are part of a broader agreement with Organon for exclusive commercialization rights outside of China [1] Group 2: Investment Activity - Boyu Capital has increased its holdings in Fuhong Hanlin, purchasing 262,500 shares and 80,000 shares on November 6 and November 10, respectively, raising its stake from 5.84% to 7% [1] - Earlier in the year, on June 18, Boyu Capital had already invested HKD 21.2673 million to increase its stake from 4.89% to 5.15%, surpassing the 5% threshold for reporting [1]

Core Viewpoint - Boyu Capital has increased its stake in Shanghai Henlius Biotech, Inc. by purchasing 262,500 and 80,000 H-shares, raising its holding from 5.84% to 7% [1][2]. Group 1: Investment Activity - Boyu Capital previously invested HKD 21.27 million to increase its stake from 4.89% to 5.15% on June 18, 2023, crossing the 5% threshold [2]. - The recent purchases reflect Boyu Capital's confidence in the core value and sustainable development potential of Shanghai Henlius in the innovative biopharmaceutical sector [2][3]. Group 2: Product Development and Clinical Progress - Shanghai Henlius has a robust pipeline with key products such as the anti-PD-1 monoclonal antibody Hansizhuang and the PD-L1 ADC HLX43, which have received international recognition for their clinical value [2][3]. - Recent data presented at the "2025 International Lung Cancer Frontier and Innovation Forum" confirmed the efficacy of HLX43 and HLX07, further enhancing market confidence in the company's R&D capabilities [3][5]. Group 3: Commercialization and International Collaboration - The company has established a diverse product matrix and has received global approvals for nine products, with four applications accepted by regulatory agencies in China, the US, and Europe [5]. - Shanghai Henlius has formed commercial partnerships with over 20 international pharmaceutical companies, covering major markets in Europe and the US, which supports its revenue growth [6]. - The company reported a significant increase in overseas product profits, with a 280% year-on-year growth in cash flow from BD contracts, indicating strong future revenue potential [6]. Group 4: Industry Outlook - As the biopharmaceutical industry enters a phase of high-quality development, companies with strong R&D capabilities and mature commercialization systems will become increasingly competitive [8]. - The continuous investment by top-tier capital like Boyu Capital serves as a testament to the intrinsic value demonstrated by Shanghai Henlius through solid clinical data [8].

Core Insights - Merck's PD-1 monoclonal antibody, Keytruda, has achieved over $20 billion in annual sales for both 2023 and 2024, solidifying its position as a leading drug in the lung cancer treatment market [2] - A competitive race is underway among pharmaceutical companies to establish the next generation of immune therapies for lung cancer, with significant advancements being made in the field [3][4] Group 1: Company Developments - Jun Zhu, CEO of Junshi Biosciences, announced promising results for their PD-L1 ADC HLX43 in treating non-small cell lung cancer (NSCLC), with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients [3] - HLX43 demonstrated even better efficacy in non-squamous patients, achieving an ORR of 48.6% and a DCR of 94.3% [3] - Junshi plans to advance at least eight Phase III clinical trials for HLX43 in the lung cancer domain [3] Group 2: Industry Trends - Lung cancer remains the leading malignancy globally, with 2.4 million new cases annually, and is a critical area for pharmaceutical breakthroughs [4] - The rise of targeted and immune therapies has transformed the treatment landscape for lung cancer, with new modalities such as ADCs, bispecific antibodies, and tumor vaccines expanding treatment options [4] - Several domestic companies, including Junshi Biosciences, CanSino Biologics, and Innovent Biologics, are competing to develop next-generation immune therapies, focusing on PD-(L)1 combinations with ADCs or PD-1 bispecific antibodies [4][5] Group 3: Clinical Research and Development - CanSino Biologics is conducting eight Phase III clinical trials for their PD-1/VEGF bispecific antibody, Ivoris, in lung cancer [6] - Innovent Biologics announced a collaboration with Takeda Pharmaceutical to co-develop a new generation immune therapy, IBI363, which targets PD-1 and IL-2α-bias [7] - Junshi's HLX43 is currently leading in global development for PD-L1 ADCs, with plans for clinical studies in cervical cancer, esophageal squamous cancer, and colorectal cancer [8]