10月8-10日，2024年世界制药原料展（CPHI Worldwide）在意大利米兰国际展览中心（Fiera Milano, Italy）举行。复宏汉霖以“The partner of choice”为主题，展示了公司6款已上市产品，丰富的在研生物药产品管线以及国际化的研产销一体化生物制药平台。展会期间，复宏汉霖吸引了大量专业观众驻足和交流，并参与了250多场会面。
作为全球最大的制药行业专业展览会，CPHI Worldwide迄今已经成功举办35届。本次展会期间，在“The Partner of Choice”为主题的生物药国际化经验交流会上，复宏汉霖药政事务部副总经理严皓珩从药政监管角度就中国生物类似药加速国际化进程的实践经验发表主题演讲。随后，公司总裁黄玮、高级副总裁兼首席商务发展官曹平、高级副总裁兼首席技术官许胜昌、严皓珩等嘉宾共同参与了以“Innovation Spirit and Partnership Philosophy at Henlius”为主题的专题讨论，现场反应热烈，多位合作伙伴到场交流互动。
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复宏汉霖高级副总裁、首席商务发展官 曹平女士：
CPHI Worldwide汇集了全球制药行业的领先企业和专业人士。在这里，我们不仅能够深入探讨行业最前沿的技术动态，还能够与行业专家与同业广泛交流，分享彼此的成功经验与实践成果。更重要的是，这为复宏汉霖提供了拓展全球合作网络的绝佳机会，帮助我们发现更多潜在的合作伙伴。通过深化国际合作，我们有信心继续推进公司在生物制药领域的创新举措，努力为全球患者提供高质量且可负担的创新药物。
本次展会期间，复宏汉霖于14A20展台展示了丰富的产品管线，包括中国首个生物类似药汉利康®（利妥昔单抗）、中美欧三地获批的单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名Zercepac®）和全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗）等。其中，汉曲优®作为中国单抗生物类似药的“出海先驱”，已在全球49个国家和地区获批，为获批上市国家和地区最多的国产单抗生物类似药，累计惠及超过21万名患者。创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并于印尼、泰国、柬埔寨等东南亚国家获批，累计惠及逾8万名患者，近期亦获得欧盟委员会积极意见，有望进一步推动全球更多患者获益。
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依托商业合作伙伴丰富的商业化经验，复宏汉霖不断加快产品在全球主流生物药市场和新兴国家市场的布局。2024年，公司与Sermonix达成亚洲区域合作，共同推进乳腺癌新型内分泌疗法HLX78（拉索昔芬）的临床阶段研发；此外，公司还与甫康药业合作，推动汉奈佳®（奈拉替尼）的商业化进程。近日，汉奈佳®的首批处方已在全国落地，标志着该药物进入临床应用并加速其商业化步伐。公司亦携手Accord、Eurofarma、KGbio、Organon等国际合作伙伴加速推进更多产品在全球的上市注册进程，共同助力中国生物医药创新与全球化发展。
展望未来，复宏汉霖将继续以临床需求为导向，深耕肿瘤、自身免疫性疾病等领域，深化产品创新、市场拓展和国际合作，夯实国际化的“研产销一体”能力，进一步推动中国生物医药行业的创新成果走向国际化，为全球更多患者带来福音。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
Henlius Shines at CPHI Worldwide 2024, Expanding New Opportunities for International Collaboration
From October 8 to 10, the CPHI Worldwide 2024 was held at Fiera Milano in Italy. With the theme of "The Partner of Choice", Henlius showcased 6 launched products, its robust biologic pipeline and integrated global biopharmaceutical platform. Henlius drew a large crowd at the booth, and concluded the conference with over 250 meetings.
As the largest professional exhibition in the global pharmaceutical industry, CPHI Worldwide has successfully held 35 editions to date. During the exhibition, the company held an experience sharing seminar themed "The Partner of Choice." At the seminar, Sandy Yan, Deputy GM of Regulatory Affairs at Henlius, delivered a keynote speech on the experiences of accelerating the internationalization of China's biosimilars from a regulatory perspective. Following this, together with Sandy, the company's President Wei Huang, Senior Vice President and Chief Business Development Officer Ping Cao, and Senior Vice President and Chief Technology Officer Simon Hsu participated in a panel discussion titled "Innovation Spirit and Partnership Philosophy at Henlius", which received enthusiastic responses and saw active interactions with several partners in attendance. This sharing seminar helped Henlius establish connections with many potential partners and clients, facilitating in-depth discussions on future collaboration opportunities.
Ping Cao, Senior Vice President and Chief Business Development Officer at Henlius, stated, "CPHI Worldwide brings together leading companies and professionals from the global pharmaceutical industry. We can not only delve into cutting-edge industry technologies but also engage in extensive exchanges with industry experts and peers, sharing success stories and practical outcomes. More importantly, it provides Henlius with an excellent opportunity to expand global cooperation network and identify more potential partners. Through deepening international collaboration, we are confident in continuing to advance the company's innovative initiatives and striving to provide high-quality and affordable biologics for patients worldwide."
During the exhibition, Henlius showcased 6 launched products at Booth #14A20, including HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in all China, Europe and the U.S., and its innovative product HANSIZHUANG (serplulimab), the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer.
Standing as the “pioneer in going global” for China-developed mAb biosimilar, Henliu has got its core oncology product HANQUYOU approved in 49 countries and regions around the world, making it the China-developed mAb biosimilar with the most marketing approvals. Until now, it has benefited more than 210,000 patients. The innovative product HANSIZHUANG has been approved in China for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer, extensive-stage small cell lung cancer, and esophageal squamous cell carcinoma. It has also been approved in Southeast Asian countries such as Indonesia, Thailand, and Cambodia, benefiting over 80,000 patients in total. Recently, Henlius received positive opinion from EMA CHMP for HANSIZHUANG as first-line treatment for extensive-stage small cell lung cancer, which is expected to further benefit more patients globally.
Leveraging the extensive commercialization experience of its business partners, Henlius is continually accelerating the expansion of its products in major markets as well as emerging markets. In 2024, Henlius expanded its collaboration with Sermonix in all of Asia to jointly advance the clinical development of the investigational novel targeted endocrine therapy HLX78 (lasofoxifene). Furthermore, Henlius reached cooperation with Convalife to further promote the commercialization of neratinib (trade name: HANNAIJIA). Recently, the first prescriptions for HANNAIJIA have been launched nationwide, marking its entry into clinical application and accelerating its commercialization process. Meanwhile, the company joined hands with international partners such as Accord, Eurofarma, KGbio and Organon to accelerate overseas registratoin and commercialization of its products, collectively advancing the innovation and globalization of China's biopharmaceutical industry.
Looking ahead, Henlius will remain focused on clinical needs, with a strong emphasis on oncology, autoimmune diseases, and other key areas. The company will continue to drive product innovation, expand its market presence, and deepen international cooperation to strengthen its global integrated platform of R&D, production, and commercialization. These efforts will further advance the internationalization of China’s biopharmaceutical innovations, delivering benefits to more patients worldwide.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has proactively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.
