Henlius Trastuzumab Receives FDA Approval in the United States

Shanghai, China, April 26, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI? (HLX02, trastuzumab-strf, biosimilar to Herceptin^® trade name: HANQUYOU in China and Zercepac^® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.

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Mr. Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius remarked, “Henlius independently developed HLX02 in accordance with the NMPA, the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius' response to patients' concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics.”

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“Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we’re just getting started.?We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings,” said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. “Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”??

“The approval of HERCESSI - our first biosimilar to be approved in the U.S. - marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, U.S. president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”

HLX02 to benefit global patients

Breast cancer is the second most diagnosed cancer ^[1]. According to the American Cancer Society, over 370,000 new cases of breast cancer will be diagnosed in the U.S. in 2024, ranking first in the country's cancer incidence rates and showing year-over-year growth ^[2]. About 15% to 20% of breast tumors are HER2-positive breast cancers ^[2]. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23% ^[3]. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers. Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, HERCESSI? in the U.S., Zercepac^® in Europe) has been successfully approved in more than 40 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania, and it is reimbursed nationally in countries and regions including China, the United Kingdom (UK), France and Germany. To date, HLX02 has benefited more than 180,000 patients.

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HLX02 (trade name: HANQUYOU in China, HERCESSI? in the U.S., Zercepac^® in Europe) was granted approval by the FDA based on a comprehensive package of analytical, pre-clinical and clinical study data submitted by Henlius. Since 2015, Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study. The data indicates that HLX02 is highly similar to reference trastuzumab in terms of quality, safety, and efficacy.

Henlius Quality in line with highest quality standards

HLX02 (trade name: trade name: HANQUYOU in China, HERCESSI? in the U.S., Zercepac^® in Europe) has received recognition from global regulatory authorities for its longstanding commitment to maintaining manufacturing systems that comply with the highest quality standards. In 2023, the manufacturing site and facility where HLX02 is manufactured underwent and successfully passed the Pre-License Inspection (PLI) by the FDA. The success of the FDA PLI, as well as the previous GMP certifications from China and EU regulatory agencies, make Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs.

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Henlius has established a quality management system in accordance with the highest quality standards. The system covers the entire product life cycle from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Southeast Asia, Europe, and Latin America. The company's commercial production facilities and supporting quality management system have passed on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person, as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies.

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Henlius has aggressively pursued international commercialization of HLX02 and is actively collaborating with global partners such as Accord, Abbott, Eurofarma, and Elea to bring its therapeutics to patients in the U.S., Canada, Europe, and other emerging markets, covering about 100 countries and regions. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.