30 October 2023 | Monday | News
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Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commercial milestone payments
Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb. In June 2018, Henlius and Accord Healthcare Ltd., a subsidiary of Intas, entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip®/Trastucip®) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.
This collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab's global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed territory.
"With superior efficacy and data quality, HANSIZHUANG (serplulimab) has become the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023," said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. "By continuously partnering with Intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes."
Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac® in Europe), which has been successfully approved in 40+ overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world."
Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve."
Paul Tredwell, Executive Vice President of EMENA., Accord, said, "I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients."
The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., enrolling more than 3,600 subjects globally. And the proportion of Caucasians is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical applications all over the world in the future.
In 2022, serplulimab was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable it to benefit from certain policy support for research and development, registration, and commercialisation in the U.S. and Europe. The EMA has validated the application for serplulimab and it is expected to be approved in the first half of 2024. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval.
In the meantime, Henlius pro-actively advances the commercialisation of HANSIZHUANG in overseas markets at high speed. Henlius granted KGbio exclusive rights to develop and commercialize HANSIZHUANG in 10 ASEAN member countries and 12 MENA countries. Furthermore, Henlius and Fosun Pharma have entered into an exclusive license agreement for HANSIZHUANG in the U.S. HANSIZHUANG's coverage footprint now includes the U.S., Europe, Southeast Asia, MENA, and India.
In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of HANSIZHUANG globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.