Shanghai, China, Dec 27^th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into an exclusive license agreement with Fosun Pharma（600196.SH，02196.HK） for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG in the United States (US).

According to the terms of the agreement, Fosun Pharma will have the right to commercialise HANSIZHUANG upon approval in the US, and Henlius will retain responsibility for development, manufacturing, and supply. Henlius will receive RMB 1 billion as upfront payment and milestone payments and is entitled to receive royalties in the partnered territory. For many years, the two companies have worked closely on product commercialisation and other areas, developing consensus in terms of corporate vision and values, global development strategy, product operations, and management communication while focusing on patients’ and clinical needs. Through this collaboration, the two parties aim to intensively develop HANSIZHUANG, integrate superior resources, and promote its rapid launch in the United States to benefit more patients.

Mr. Wu Yifang, Chairman of Fosun Pharma, said “We are very happy to make full use of Fosun Pharma's accumulated innovation capabilities, internationalization advantages and commercialization capabilities over the years to promote the commercialization of the anti-PD-1 mAb HANSIZHUANG in the US market and help benefit more patients around the world. Fosun Pharma has always been patient-centered and clinical needs-oriented. We have been practicing internationalization strategies in the dimensions of innovative R&D, license introduction, production operation and commercialization, and continuously strengthening the construction of full capacity in global operations.”

Mr. Wenjie Zhang, Chairman and CEO of Henlius, said, “We are excited to partner with Fosun Pharma in the United States on HANSIZHUANG. The impressive clinical data of HANSIZHUANG was published in the top international medical journal and has gained international attention. As we move forward, we’ll seek approvals for additional indications in China, the US, and the European Union. In the US, Fosun Pharma has a fast-growing commercialisation team and a dedicated sales network. Together, we will accelerate the launch of this differentiated anti-PD-1 mAb in the US market and benefit more overseas patients with high-quality biological drugs.”

Joining Forces for a Global Blueprint

Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma strengthens its independent R&D and external cooperation and enriches its product pipelines, as well as promotes global networks. Thanks to its industry-leading two-way licensing capabilities and international advantages, Fosun Pharma helps maximize the value of innovative products of partners. In the international layout, Fosun Pharma focuses on building the US operation center and conducts all-around capacity building in R&D, production, and sales in the local market. On the important partnership in the US for serplulimab, and the potential impact on patients with lung cancer, Rong Yang, Senior Vice President of Fosun Pharma and CEO of Fosun Pharma USA Inc. said, “It is a very important step for us, an opportunity to be a part of the community, and serving patients with critical unmet needs, and making a difference every day. ”

Fully leveraging the experience of biologics development and harnessing the power of innovation, Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle, including R&D, manufacturing and commercialisation, laying the solid foundation for a diversified and robust innovation pipeline. Up to date, 5 products have been successfully marketed in China, and 1 approved for marketing in overseas markets. The pipeline of products under development covers targets with great market potential, such as PD-1, HER2, EGFR, BRAF, etc. Synergising the innovation centres in China and the US and global product development teams, the company continues the momentum for a diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing capabilities, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. The products in the pipeline are produced by the company’s self-built manufacturing facilities, with rich production experience from clinical stages to commercialised products. Also, the manufacturing facilities have successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency, the EU qualified person, and multiple international business partners, and are certified by China and EU GMP. Henlius’ strong R&D capabilities, international-standard quality management system, and production capacity enable the company to boost the global commercialisation of its products.

Chinese Biologics in Global League

HANSIZHUANG is the first innovative mAb developed by Henlius. To date, 2 indications are approved for marketing in China, and 2 NDAs have been accepted by the National Medical Products Administration (NMPA). Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer, benefiting more than 10,000 Chinese patients. Henlius actively promotes the synergy between HANSIZHUANG and other in-house products and innovative therapies and carries out 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, including lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer. Moreover, HANSIZHUANG has covered the full range of first-line treatments for lung cancers. The results of ASTRUM-005, a phase 3 study of HANSIZHUANG as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), became the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. Also, HANSIZHUANG has been granted Orphan Drug Designation (ODDs) for the treatment of small cell lung cancer (SCLC) by the FDA and the European Commission (EC), respectively.

Furthermore, Henlius has collected an extensive collection of global clinical trial data through the efficient operations of overseas clinical trials and continues to promote products to accelerate their globalisation. Previously, Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialise HANSIZHUANG in relation to its first monotherapy and two combination therapies in 10 Asia Pacific countries. Following the license granted in Southeast Asia, it is now further extended to the US market. Based on the positive feedback of the US Food and Drug Administration (FDA) Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and the discussion results of the FDA’s Class C consultation meeting, Henlius plans to recruit 100 pairs of US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which is expected to propel the product towards US market approval further. Through overseas development of HANSIZHUANG, Henlius will accelerate the pace of global internationalisation and deliver more high-quality, affordable treatment options to patients.

About HANSIZHUANG

HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended for the treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC), and the associated clinical trial became the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designations by the FDA and EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well ascentral nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.

For more information, please visit our official website: www.fosunpharma.com.

PR source:- Henlius