重磅！复宏汉霖获欧盟GMP证书

Henlius 复星 2022-01-19

内容转载自：复宏汉霖

2020年4月23日，复宏汉霖（2696.HK）宣布，公司已经顺利通过HLX02曲妥珠单抗原液（DS）和制剂（DP）线的欧盟GMP现场核查，正式获得波兰卫生监督机构Chief Pharmaceutical Inspector签发的两项欧盟GMP证书（Certificate of GMP Compliance of a Manufacturer）。欧盟GMP认证是国际公认的最权威和严谨的认证之一，不仅在近30个成员国之间彼此互认共享，同时也可与美国、加拿大等签订互认协议（MRA）的国家共享核查结果，在全球范围内具有重大影响力，被视为药品登陆国际市场的“通行证”。

至此，复宏汉霖徐汇基地正式成为国内首个获得欧盟GMP认证用于生产自主研发抗体生物药的GMP工厂，HLX02曲妥珠单抗也成为国内首个获得欧盟GMP认证的国产生物类似药，这意味着复宏汉霖已经具备了符合欧盟标准的商业化生产基地和质量管理体系，打破了国产单抗生物药在海外上市的GMP壁垒，为公司进军国际市场奠定了坚实的基础。

复宏汉霖联合创始人、首席执行官刘世高博士表示：

“

我们对顺利通过欧盟GMP认证感到十分骄傲和自豪，这离不开整个团队十年的努力和坚守，离不开复宏汉霖对质量的不懈追求。我们将全力推进HLX02的全球商业化进程，希望在惠及更多患者的同时，代表中国去打‘世界杯’，与欧洲、美国、韩国等全球顶尖的生物制药公司同台竞技。

”

复宏汉霖总裁张文杰先生表示：

“

2019年2月，公司首个产品汉利康®（利妥昔单抗注射液）正式获得中国国家药监局批准，成为首个于中国上市的生物类似药。继汉利康®之后，HLX02曲妥珠单抗已被纳入新药上市申请优先审评程序，有望于今年上市。此次获得欧盟GMP证书，是全球权威药监机构对公司自主研发和生产的高品质生物药的再度认可。

”

坚守最高质量标准，铸就国际一流平台

欧盟是世界上最早制定生物类似药指导原则的地区。早在2004年，欧洲药品管理局（EMA）就发布了《生物类似药指南（草案）》，开创了全球生物类似药新时代。自2006年批准首个生物类似药以来，欧盟已成为全球生物类似药最主要的成熟市场。此次通过欧盟GMP认证的徐汇基地位于上海徐汇漕河泾新兴技术开发区，设计和施工均按照欧盟、中国及美国的标准执行。自复宏汉霖成立之初，公司就坚持对标国际最高水平，依照欧盟质量标准开展研发和生产工作，在临床前研究、临床试验等阶段都对生物类似药与原研药进行了头对头比较，为国际化战略的实施打下了良好基础。此前，徐汇基地及配套的质量管理体系已通过由中国国家药监局、欧盟质量受权人（QP）以及国际商业合作伙伴进行的多项实地核查及审计，并已获得国家药监局批准的《药品GMP证书》。

“中国籍”曲妥珠单抗，造福全球患者

HLX02是复宏汉霖严格按照国际标准开发和生产的生物类似药，与原研药开展了“头对头”的国际多中心（中国大陆、乌克兰、波兰和菲律宾）3期临床试验，有望用于治疗HER2阳性早期乳腺癌、HER2阳性转移性乳腺癌及HER2阳性转移性胃癌，是公司践行国际化开发战略的重要成果。在2019年度于新加坡举办的ESMO Asia年会上，HLX02国际多中心3期临床研究结果发布，研究证明了在HER2阳性复发或转移性乳腺癌患者中，HLX02和原研曲妥珠单抗具有相似的疗效和安全性。

为满足全球患者对高质量、可负担药物的用药需求，复宏汉霖已针对HLX02前瞻性地开展了国际商业化布局，积极开拓海外市场。公司陆续与Accord、Cipla、Mabxience和雅各臣药业等国际一流的生物制药企业达成合作，促进HLX02在全球80多个国家和地区的商业化进程。其中，Accord是一家全球性制药公司，专注于仿制药产品和生物仿制药的开发、制造和销售，业务覆盖北美、欧洲、澳洲、南非等地区，复宏汉霖授予其在欧洲、中东、北非地区和部分独联体国家共计70余个国家的独家商业化权利。2019年6月，公司联合Accord共同推动HLX02向欧洲药品管理局（EMA）递交营销授权申请（MAA），使得HLX02成为首个在欧盟报产并获受理的“中国籍”曲妥珠单抗，有望实现欧盟市场中国生物类似药零的突破。

未来，公司将持续践行“可负担的创新·值得信赖的品质”的核心理念，深耕肿瘤治疗领域，努力开发更多创新生物药，为全球患者提供更可负担、疗效更好的治疗选择，成为全球最受信赖和景仰的创新生物医药公司！

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，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟新药上市申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康®（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国首个获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内首个开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局上市申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。

Henlius receives EU GMP Certificate for HLX02 (Trastuzumab for Injection)

Shanghai, China, April 23, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company’s drug substance (DS) line and drug product (DP) line for HLX02 trastuzumab biosimilar have successfully passed the European United (EU) Good Manufacturing Practice (GMP) on-site inspection and the company has received two EU GMP Certificates (Certificate of GMP Compliance of a Manufacturer) from Poland’s Chief Pharmaceutical Inspector. As one of the most authoritative and rigorous inspections globally, EU GMP inspection is recognized by nearly 30 EU Member States, and the inspection results may also be shared with other countries that have signed Mutual Recognition Agreements (MRAs) with the EU, including the United States, Canada etc.. Therefore, EU GMP Certificate is regarded as a “passport” for drugs to be launched in international market and has significant global impact.

With the EU GMP Certificates, Henlius’ Xuhui Facility has become China's first EU certified GMP site to manufacture a self-developed antibody drug and HLX02 trastuzumab biosimilar is the first China-developed biosimilar that has passed the EU GMP inspection. This means that the company has already built a commercial-scale manufacturing facility and a quality management system that are in line with the EU standards. This also means that China-developed antibody drug is breaking the GMP barriers to be launched on international market, laying a solid foundation for the company to further expand its global footprints.

Dr. Scott Liu, co-founder and CEO of Henlius, said, "We are very pleased with the successful pass of the EU GMP inspection. This could never be achieved without the team’s 10-year hard work, dedication and Henlius’ pursuit of high quality. We will make every effort to accelerate the global commercialisation progress of HLX02, hoping to benefit more patients and to represent China in the ‘World Cup’ to compete with the world's top bio-pharmaceutical companies from Europe, the United States, South Korea etc.

Mr. Zhang Wenjie, President of Henlius, said, "In February 2019, the company's first product, HLX01 (rituximab injection), was officially approved by China National Medical Products Administration (NMPA), becoming the first biosimilar launched in China. Following the successful launch of HLX01, the NDA of HLX02 has been assigned to the priority review list by NMPA and HLX02 is expected to be launched this year. The EU GMP Certificates are another recognition of the company's high-quality and independently-developed products by the world's authoritative drug regulatory agencies.

Complying with the Highest Quality Standards, Building the World-class Platform

The EU has pioneered in the establishment of the regulations of biosimilar medicines in the world. In 2004, the European Medicines Agency (EMA) issued the draft biosimilar guidelines, opening up a new era for global biosimilars. Since the first biosimilar was approved in 2006, the EU has become the world's most mature market for biosimilars. The Xuhui Facility is located in Caohejing High-tech Park, Xuhui District, Shanghai, designed and built in accordance with the standards of the EU, China and the United States. Ever since its foundation, Henlius has adhered to the highest quality standards in the world and all R&D and production activities are carried out in line with EU quality standards. Head-to-head comparisons have been conducted between biosimilars and originators in the pre-clinical and clinical stages, which has laid the foundation for the company’s globalisation strategy. The Xuhui Facility and its supporting quality management system have passed a number of on-site inspections or audits by the NMPA, EU qualified person and international business partners, and have obtained a GMP certificate from the NMPA.

China-developed Trastuzumab to

Benefit Global Patients

HLX02 is a biosimilar developed and manufactured by Henlius in accordance with international standards, potentially for the treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. It was evaluated in an international multi-centre (Mainland China, Ukraine, Poland and the Philippines) Phase 3 clinical study aiming for head-to-head comparison between HLX02 and the originator, which is a key milestone of the company’s globalisation strategy. The study results were presented in the 2019 ESMO Asia Congress held in Singapore, demonstrating that HLX02 has no clinically meaningful differences from the originator trastuzumab in terms of efficacy and safety in patients with recurrent or metastatic HER2+ breast cancer.

To fulfil the huge unmet needs of high-quality and affordable biologic medicines worldwide, Henlius has proactively expanded its global presence through continuous strategic collaboration with global leading pharmaceutical companies and has reached strategic cooperation agreements with Accord, Cipla, Mabxience and Jacobson Medical for the commercialisation of HLX02 in over 80 countries and regions around the world. With an extensive presence in North America, Europe, Australia, South Africa etc., Accord has become one of the fastest growing generic pharmaceutical companies focused on developing, manufacturing and distributing generics and biosimilars. Henlius has granted Accord exclusive commercial rights of HLX02 in over 70 countries and regions in Europe, the Middle East and North Africa and the Commonwealth of Independent States. In June 2019, Accord submitted a Marketing Authorization Application (MAA) to the EMA on HLX02, making HLX02 the first China-developed trastuzumab biosimilar accepted by the EMA for MAA review, and therefore HLX02 has the potential to become the first China biosimilar approved in the EU.

Looking forward, while keeping with the core values of “Affordable Innovation · Reliable Quality”, Henlius will continue its dedication in the field of oncology and deliver more innovative biologic medicines to provide affordable and effective treatment options for patients worldwide, highlighting the company’s vision of becoming the most trusted and admired biotech company in the world.

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 and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialisation.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-center clinical trials are ongoing in various countries and regions worldwide.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com

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