复宏汉霖亮相CPHI Worldwide 2024，拓展国际合作新机遇

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。

滑动查看图片

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。

滑动查看图片

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。

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.