近日,印度尼西亚食品药品监督管理局(BPOM)局长Lucia Rizka Andalucia女士一行,在印度尼西亚制药公司PT Kalbe Genexine Biologics(以下简称“KGbio”) 董事长Sie Djohan先生的陪同下,到访复宏汉霖实地考察。复宏汉霖执行董事兼首席执行官朱俊博士等热情接待了代表团的访问,并对代表团的到来表示诚挚欢迎。
座谈会上,朱俊博士向来访人员介绍了复宏汉霖的发展历程、核心业务、研发进程及未来战略规划,展示了公司在生物制药领域的差异化创新成果和市场优势,双方还就未来的合作展开了详细交流和探讨。会后,印尼方人员参观了公司徐汇生产基地,实地考察了公司的生产工艺流程和商业化生产能力。
Lucia Rizka Andalucia女士赞扬了公司先进的创新实力和与国际质量标准接轨的质量管理体系。她表示,BPOM十分重视国际合作,期望KGbio持续携手复宏汉霖围绕多个产品展开深入合作,共同推动生物医药产业在印尼的发展,提高当地患者可及性。
2023年12月,H药于印度尼西亚获批上市,成为首个在东南亚国家成功获批上市的国产抗PD-1单抗。2024年1月,公司高效完成H药的首批海外发货,开启该产品惠及全球患者的新篇章。自2019年起,复宏汉霖携手KGbio陆续在东南亚、中东和北非地区(MENA)22个新兴市场国家推进H药的获批上市,以期令更加先进、高效的治疗方案能够真正惠及当地患者。
此次印度尼西亚药品监督管理局和KGbio的到访,不仅是复宏汉霖国际化战略的重要体现,也加深了公司与印尼BPOM及KGbio的互信与合作,为未来双方进一步合作奠定了坚实的基础。未来,复宏汉霖将继续努力,不断推动技术创新和国际合作,加速为全球患者提供可负担的高品质生物药。
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,已在中国上市5款产品,在国际获批上市3款产品,23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。继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)和汉贝泰®(贝伐珠单抗)相继获批上市,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。
Indonesian BPOM and KGbio Visit Henlius: Deepening Cooperation for Mutual Success
Recently, a delegation led by Ms. Lucia Rizka Andalucia, Acting Head of Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”), accompanied by Sie Djohan, President Director of PT Kalbe Genexine Biologics (“KGbio”), visited Henlius. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, warmly received the delegation and extended a sincere welcome.
During the meeting, Dr. Zhu presented Henlius' development history, core businesses, research progress, and future strategic plans. He highlighted the company's innovative achievements and market advantages in the field. The two sides also discussed potential future collaborations in detail. Following the meeting, the Indonesian delegation toured Henlius' Xuhui Facility to observe the company's production processes and commercial production capabilities firsthand.
Ms. Lucia Rizka Andalucia praised Henlius for its advanced innovations and quality management system, which aligns with international standards. She emphasized BPOM's commitment to international collaboration and expressed hope that KGbio would continue to work closely with Henlius on products to advance the biopharmaceutical industry in Indonesia and improve local patient accessibility.
In December 2023, HANSIZHUANG was approved in Indonesia under the trade name Zerpidio®, becoming the first Chinese anti-PD-1 mAb approved in Southeast Asia. In January 2024, Henlius successfully completed the first overseas shipment of HANSIZHUANG, marking a new chapter in making the product accessible to patients worldwide. Since 2019, Henlius has been collaborating with KGbio to progressively expand collaboration in 22 emerging market countries across Southeast Asia, Middle East and North African (MENA) countries regarding HANSIZHUANG. The two parties are actively working towards obtaining approvals in more countries, aiming to bring advanced and efficient treatment options to local patients.
The visit by the Indonesian BPOM and KGbio not only underscores Henlius' commitment to global expansion but also strengthens the mutual trust and collaboration between Henlius, Indonesian BPOM, and KGbio. This visit lays a solid foundation for further collaboration in the future.
Moving forward, Henlius will continue to strive for technological innovation and global collaboration, accelerating the provision of affordable, high-quality biologics for 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. Up to date, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 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 pro-actively 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) and HANBEITAI (bevacizumab), 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.