POHERDY®获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上 市。本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提 升公司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 此次FDA的批准主要是基于对HLX11(帕妥珠单抗)(HLX11)与其参照药(Perjeta®)一系列比对研究数据的 全面审查，包括分析相似性研究及临床比对研究。这些研究数据充分证明了HLX11与其参照药在质 量、安全性和有效性方面的高度相似。HLX11获准用于参照药Perjeta®在美国已获批的所有适应症。同 时，集团HLX11相关生产场地和设施亦接受了FDA的批准前检查(Pre-License Inspection, PLI)，该等生产 场地和设施均符合FDA的cGMP要求。 复宏汉霖(02696)发布公告，近日，集团收到美国食品药品管理局(FDA)的批准函，POHERDY® (帕妥珠 单抗)420mg/14mL(30mg/mL)注射液(供静脉注射使用)的生物制品许可申请(BLA)获FDA批准，该商品名 由N.V.Organo ...

HLX11是公司自主研发的帕妥珠单抗生物类似药。2022年6月，公司与Organon LLC(Organon&Co.的全 资附属公司)签订协议，向其授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外全 球范围内商业化HLX11。2024年12月，HLX11的上市注册申请(NDA)获国家药品监督管理局(NMPA)受 理。2025年3月，HLX11的上市许可申请(MAA)获欧洲药品管理局(EMA)受理。2025年5月，HLX11的上 市注册申请(NDS)获加拿大卫生部(Health Canada)受理。根据IQVIA MIDASTM的最新数据(由IQVIA提 供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年度，帕妥珠单抗产品于全球 范围内的销售额约为33.04亿美元。 POHERDY获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上市。 本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提升公 司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 复宏汉霖(02696)发布公告 ...

HLX11是公司自主研发的帕妥珠单抗生物类似药。2022年6月，公司与Organon LLC(Organon & Co.的全 资附属公司)签订协议，向其授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外全 球范围内商业化HLX11。2024年12月，HLX11的上市注册申请(NDA)获国家药品监督管理局 (NMPA)受 理。2025年3月，HLX11的上市许可申请(MAA)获欧洲药品管理局(EMA)受理。2025年5月，HLX11的上 市注册申请(NDS)获加拿大卫生部 (Health Canada)受理。根据IQVIA MIDASTM的最新数据(由IQVIA提 供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年度，帕妥珠单抗产品于全球 范围内的销售额约为33.04亿美元。 POHERDY®获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上 市。本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提 升公司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 智通财经APP讯，复 ...

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 ...

Financial Data and Key Metrics Changes - Alvotech reported total revenues of $420 million for the first nine months of 2025, representing a strong 24% year-on-year growth [22] - The company revised its full-year revenue guidance to a range of $570 million-$600 million and adjusted EBITDA to $130 million-$150 million following a Complete Response Letter (CRL) from the FDA [11][26] - Adjusted EBITDA for the first nine months was $68 million, or 16% margin, compared to 26% the previous year, driven by higher R&D investments [24] Business Line Data and Key Metrics Changes - Licensing revenues in Q3 were at a high level of $81 million, supporting a strong gross margin of 69% [21] - The product margin for Q3 was 27%, reflecting softness due to timing of orders and facility improvements [22] - Alvotech's revenue growth averaged 127% per year from 2021 to year-end 2024, with a projected compounded average growth rate of 94% from 2021 to the end of 2025 [12] Market Data and Key Metrics Changes - In the U.S., Alvotech holds the second-largest market share in the Humira biosimilar segment, with products being the fastest-growing in that category [13] - In Europe, the biosimilar Yukindra has seen average quarter-on-quarter growth of 12% over the last four quarters and holds top positions in several major EU markets [13] - The company expects 50% of Stelara's European market to transition to biosimilars by year-end [14] Company Strategy and Development Direction - Alvotech aims to lead the biosimilar market, having invested approximately $2 billion in building a global biosimilar company with integrated R&D and manufacturing [4] - The company has expanded its R&D capabilities with a new operational base in Sweden and has a pipeline targeting over $185 billion of originated markets [6] - The strategic focus for the next 18 months includes advancing the pipeline, executing multiple global launches, and driving cost optimization [27] Management Comments on Operating Environment and Future Outlook - Management expressed disappointment over the CRL but remains committed to resolving outstanding issues and anticipates approval of the BLA as early as the first half of 2026 [10] - The company expects strong growth in 2026, driven by committed orders for new launches and growth momentum in currently marketed products [27] - Management emphasized the importance of maintaining in-house R&D and manufacturing to ensure quality and compliance with regulatory standards [35] Other Important Information - Alvotech has five approved biosimilars and 12 other disclosed development programs, with additional cell lines developed for 15 valuable targets [6] - The company finalized the integration of Ivers-Lee, a Swiss-based assembly and packaging service provider, to increase capacity for finished product assembly [21] Q&A Session Summary Question: Can you explain the observations related to the CRL? - Management clarified that the observations were not repeat issues and that over 180 changes have been committed to the FDA, with 93% already completed [32][33] Question: How does the CRL impact conversations with customers? - Management noted that there has been no reduction in interest from clients, and they continue to keep key clients updated on quality system improvements [41] Question: What is the expected impact of the manufacturing process changes on revenue? - Management indicated that the revision in guidance reflects both production slowdowns and the timing of licensing agreements shifting to 2026, impacting Q4 EBITDA significantly [46] Question: What amendments have been made to production lines? - Management detailed improvements in manufacturing controls and documentation practices, with ongoing production expected to return to full capacity [52][56] Question: How will regulatory changes affect earlier stage biosimilars? - Management stated that they anticipated regulatory changes and adjusted their R&D strategy accordingly, positioning themselves well for future developments [62]

Financial Data and Key Metrics Changes - Alvotech reported total revenues of $420 million for the first nine months of 2025, representing a strong 24% year-on-year growth [22] - Adjusted EBITDA for the first nine months was $68 million, or 16% margin, compared to 26% last year, driven by higher R&D investments [24] - The company revised its full-year revenue outlook to a range of $570 million-$600 million and adjusted EBITDA range of $130 million-$150 million following a Complete Response Letter (CRL) from the FDA [26] Business Line Data and Key Metrics Changes - Licensing revenues were at a high level of $81 million in Q3, supporting a strong gross margin of 69% [21] - The product margin was reported at 27%, reflecting softness in Q3 due to timing of orders and facility improvements [22] - Alvotech's revenue growth has averaged 127% per year from 2021 to year-end 2024, with a projected compounded average growth rate of 94% from 2021 till the end of 2025 [12] Market Data and Key Metrics Changes - In the U.S., Alvotech holds the second-largest market share in the Humira biosimilar segment, with products being the fastest-growing in this category [13] - In Europe, the biosimilar Yukindra has seen average quarter-on-quarter growth of 12% over the last four quarters and holds top positions in several major EU markets [13] - The company expects 50% of Stelara's European market to transition to biosimilars by year-end [14] Company Strategy and Development Direction - Alvotech aims to lead the biosimilar market, having invested approximately $2 billion in building a global biosimilar company with integrated R&D and manufacturing [4] - The company has expanded its R&D capabilities with a new operational base in Sweden and has a pipeline targeting over $185 billion of originated markets [6] - The strategic focus for the next 18 months includes advancing the pipeline, executing multiple global launches, and driving cost optimization for margin expansion [27] Management Comments on Operating Environment and Future Outlook - Management expressed disappointment over the CRL but remains committed to resolving outstanding issues and anticipates approval of the BLA as early as the first half of 2026 [10] - The company expects strong growth in 2026, driven by committed orders for new launches and growth momentum in currently marketed products [47] - Management emphasized the importance of maintaining in-house R&D and manufacturing to ensure quality and compliance with regulatory standards [35] Other Important Information - Alvotech has five approved biosimilars and 12 other disclosed development programs, with over 15 cell lines completed for future development [6] - The company finalized the integration of Ivers-Lee, a Swiss-based assembly and packaging service provider, to increase capacity for finished product assembly [21] - The cash balance at the end of September was $43 million, reflecting outflows related to inventory build-up and CAPEX investments [23] Q&A Session Summary Question: Can you explain the observations from the CRL and the status of improvements? - Management confirmed that there were no repeat observations from the FDA and that 93% of the commitments to address the observations have been completed [32][33] Question: How does the CRL impact conversations with customers? - Management noted that there has been no reduction in interest in their products, and they keep clients updated on quality system improvements [41] Question: What is the expected impact of the manufacturing process changes on revenue? - The revision in guidance reflects both production slowdowns and the shifting of some licensing agreements to 2026, impacting Q4 EBITDA significantly [46] Question: Can you confirm the timeline for fixing the production issues? - Management indicated clear visibility on the timeline for production adjustments and expressed confidence in meeting year-end targets [48] Question: How will regulatory changes impact earlier stage biosimilars? - Management stated that they anticipated regulatory changes and adjusted their R&D strategy accordingly, positioning themselves to leverage these changes effectively [64]

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 - The application for the marketing authorization of the drug "Patuzumab Injection" developed by the subsidiary of the company, Shijiazhuang Yiling Pharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration of China for the treatment of HER2-positive breast cancer [1] Group 1: Product Information - The product is a recombinant humanized anti-HER2 monoclonal antibody injection, administered once every three weeks [1] - It works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The product also mediates antibody-dependent cell-mediated cytotoxicity [1] Group 2: Clinical Trial and Efficacy - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that the product is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] - The safety and tolerability of the product are good and comparable to the reference drug [1] Group 3: Development and Research Compliance - The development of the product follows the guidelines for biosimilar drug research, confirming its high similarity in quality, safety, and efficacy to the reference drug through a series of rigorous studies [1] - The studies include pharmaceutical, non-clinical, human pharmacokinetics, clinical efficacy, and safety assessments, ensuring there are no clinically meaningful differences [1]

Core Viewpoint - The application for the listing of the drug Patuzumab Injection developed by the subsidiary of the company has been accepted by the National Medical Products Administration of China, targeting HER2-positive breast cancer [1] Group 1: Product Details - Patuzumab Injection is a recombinant humanized anti-HER2 monoclonal antibody administered every three weeks [1] - The drug works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The product also mediates antibody-dependent cell-mediated cytotoxicity [1] Group 2: Clinical Trial and Approval - The application is based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that the product is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] - The safety and tolerability of the product are comparable to the reference drug [1] Group 3: Research and Development Compliance - The development of the product follows the guidelines for biosimilar drug research, confirming its high similarity in quality, safety, and efficacy to the reference drug through a series of rigorous studies [1] - The studies include pharmaceutical, non-clinical, human pharmacokinetics, clinical efficacy, and safety assessments [1]

Core Insights - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, targeting the orthopedic and oncology fields respectively [1][2] Group 1: Product Details - BA6101 is a biosimilar to Prolia® and was approved in China in 2022, receiving positive feedback from doctors and patients during its clinical application [1] - BA1102 is a biosimilar to Xgeva® and is set to be approved in China in 2024 [2] Group 2: Indications and Applications - BA6101 aims to treat osteoporosis in postmenopausal women and high-risk men, significantly reducing the risk of vertebral, non-vertebral, and hip fractures [1] - BA1102 is intended for preventing skeletal-related events in adults with advanced malignancies and treating patients with giant cell tumors of bone [2] Group 3: Global Strategy and Market Potential - The company is pursuing international clinical and registration efforts for both products, planning submissions to EMA, FDA, and PMDA [2] - The global market for denosumab is promising, with projected combined sales of Prolia® and Xgeva® reaching approximately $6.6 billion in 2024 [2] - The company has established a quality management system compliant with international standards to support the global commercialization of denosumab and future biopharmaceuticals [2]