Hanquyou® (Zercepac®) Global Launch: Building a Patient-Centric Health Ecosystem with the Commitment 'Leaving No HER2-Positive Patient Behind'

On August 29, the Shanghai Biopharmaceutical Industry Internationalization Development Forum and the Launch of the First Domestically Produced Trastuzumab (Hanquyou) were held. The event was guided by the Shanghai Municipal Development and Reform Commission, the Shanghai Municipal Economy and Informatization Commission, the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Health Commission, and the Shanghai Municipal Medical Products Administration; organized by the China Pharmaceutical Innovation Promotion Association, the Shanghai Biopharmaceutical Industry Association, and the Shanghai Biopharmaceutical Science and Technology Industry Promotion Center; and undertaken by Shanghai Henlius Biotech, Inc.^®) The launch press conference was held in Shanghai, announcing Hanquyou, China's first domestically produced trastuzumab^®(EU brand name: Zercepac^®) approved for marketing in China and the European Union, will bring more treatment options to a broad population of patients with HER2-positive breast cancer and gastric cancer. As the first “Chinese-origin” monoclonal antibody biosimilar to enter the EU market, Hanquyou^®It is poised to cover nearly 80 countries and regions worldwide, ushering in a new chapter in the internationalization of China’s biopharmaceutical R&D achievements. Meanwhile, committed to continuously building and refining an integrated healthcare ecosystem for HER2-positive patients, Henlius officially launched its public welfare initiative, “Leave No HER2-Positive Patient Behind,” at the conference, with the aim of benefiting more patients with HER2-positive breast and gastric cancers.

Mr. Fu Daxu, Director of the Shanghai Biomedical Science and Technology Industry Promotion Center, on behalf of the organizers—the Shanghai Biomedical Industry Association and the Shanghai Biomedical Science and Technology Industry Promotion Center—extended his welcome and gratitude to all attendees. He stated, “In 2020, the outbreak of the COVID-19 pandemic posed a significant challenge globally, particularly for our colleagues in the pharmaceutical industry. It is commendable that scientists and entrepreneurs in China’s biomedical sector have risen to the occasion, contributing their wisdom and strength to the fight against the epidemic. Henlius stands out as a representative enterprise in this effort. The biomedical industry demands long-term strategic focus and sustained resilience. This time, Hanquyou^®"Having received marketing approval in both China and Europe, we deeply appreciate the arduous journey of a decade-long R&D effort. We are even more encouraged by Henlius’s determination and confidence, as a leading Chinese biosimilar company, in steadfastly advancing its internationalization strategy. We look forward to this Forum on the International Development of the Biopharmaceutical Industry providing forward-looking perspectives for scientific research and industrialization in the field of oncology. We also anticipate that Henlius, as a member unit of the Shanghai Biopharmaceutical Industry Association, will make new and greater contributions to the high-quality development of Shanghai’s biopharmaceutical industry."

Mr. Song Ruilin, Executive President of the China Pharmaceutical Innovation Promotion Association, delivered congratulatory remarks via a pre-recorded video for the launch event, stating, “The domestically produced trastuzumab, Hanquyou^®The successful market launch is not only a testament to Henlius’s achievements in technological development and commercial operations, but also a symbol of the significant progress made in China’s pharmaceutical innovation. It will greatly meet the medication needs of Chinese patients with breast cancer and gastric cancer, reduce treatment costs, and hold profound positive significance for societal development. In recent years, with the reform of China’s drug regulatory system, the spring of pharmaceutical innovation in China has arrived. Through Hanquyou^®With its market launch, we are also witnessing a large cohort of Chinese pharmaceutical innovation enterprises, including Henlius, embarking on a path of robust growth. We sincerely hope that Chinese pharmaceutical innovators represented by Henlius will go further and achieve greater success in their future innovation endeavors, bringing the benefits of independently developed innovative drugs to a broad patient population.”

Mr. Wu Jinglei, Director of the Shanghai Municipal Health Commission and Deputy Secretary of the Party Leadership Group, stated, “During this year’s fight against the epidemic, we have deeply felt the critical role played by independently developed domestic pharmaceutical products in building a Healthy China. The successive approval and market launch of two products by Henlius have promoted the development of China’s biopharmaceutical industry, which is of great significance to the implementation of the Healthy China strategy and the great rejuvenation of the Chinese nation. We look forward to more enterprises like Henlius leveraging technological support and being guided by public needs in product research and development, continuously introducing new high-quality drugs, so that Chinese patients can truly access and afford high-quality domestically produced medicines.”

Mr. Liu Ping, Chief Engineer of the Shanghai Municipal Commission of Economy and Informatization, delivered an address: “Shanghai is making every effort to build a highland for biomedical industry innovation with international influence. Henlius’s Hanquyou^®approval in China and Europe is a significant manifestation of the construction of such a highland for biomedical innovation. We believe that Hanquyou^®"The successful market launch will not only benefit breast and gastric cancer patients both in China and abroad, but also represent Shanghai and China in competing in the global biopharmaceutical industry, contributing to the well-being of people worldwide. We also look forward to Henlius further playing its role as a main force and pioneer in the biopharmaceutical industry, accelerating the industrialization of innovative achievements, and playing a greater role in building a globally influential hub for the biopharmaceutical industry."

Ms. Zhang Qing, Deputy Director of the Shanghai Municipal Medical Products Administration, on behalf of the Shanghai Municipal Medical Products Administration, for Hanquyou^®She extended her warm congratulations on the approval in Central Europe, stating, “In 2019, I had the privilege of witnessing Hanlikang, the first biosimilar^®approval for market launch. More than a year later, Henlius has achieved remarkable success with another product, Hanquyou^®"Simultaneous approval in China and Europe. Meanwhile, the successful market launch of Henlius’s products also bears witness to the continuous reform, optimization, and implementation of China’s drug regulatory policies and systems. In this process, Henlius, along with Fosun Pharma, has made significant contributions to the formulation of relevant regulations and guidelines. Looking ahead, I expect Henlius to play a greater leading role, not only by enhancing its own professional capabilities but also, through collective efforts, by elevating the standards of the entire industry, as well as those of Shanghai and China as a whole."

Mr. Chen Qiyu, Co-CEO of Fosun International, Chairman of Fosun Pharma, and Chairman of Henlius, stated: “2020 was a year full of challenges and responsibilities for Chinese biopharmaceutical companies, but also a year filled with hope and harvest. It is gratifying to see Henlius successfully launch Hanlikang, China’s first biosimilar.”^®Subsequently, more good news arrived: Henlius’s second product, Hanquyou^®Securing dual approval in China and Europe has broken the GMP barriers for Chinese-made biosimilars going global, paving the way for overseas market entry of domestically produced biologics. Hanquyou^®The successful approval would not have been possible without the policy support from the government and drug regulatory authorities, nor without the trust and contributions of industry experts, healthcare professionals, patients, and their families. Looking ahead, Fosun Pharma and Henlius will strive for higher-level innovation, accelerating the research and development of innovative biologics while promoting the internationalization of domestically produced biosimilars, thereby benefiting patients in China and around the world with more innovative achievements.”

Hanquyou®^®Henlius independently developed and manufactured this monoclonal antibody biosimilar in accordance with the biosimilar regulations of the European Union and China. It demonstrates high similarity to the originator trastuzumab in terms of quality, safety, and efficacy, and is indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer. According to Mr. Li Hanjun, Senior Director of IQVIA’s Consulting Business, monoclonal antibody biologics have been the fastest-growing category within the biologics sector over the past five years. However, due to characteristics such as high R&D barriers, complex process development, and stringent production requirements, the development of monoclonal antibodies involves long cycles and substantial investment. Hanquyou^®The successful approval, achieved after a decade of effort, was made possible by the company’s unwavering commitment to patient interests, as well as by supportive national policies and the collaborative efforts of regulatory authorities, healthcare service providers, and other stakeholders. Throughout the entire R&D and commercialization journey, Hanquyou^®It pioneered multiple firsts in China’s biosimilar sector, becoming the first domestically produced biosimilar to conduct international multi-center Phase 3 clinical trials, the first “Chinese” monoclonal antibody biosimilar to receive EU GMP certification, and the first domestically produced monoclonal antibody biosimilar approved for marketing in both China and Europe.

According to Dr. Jiang Weidong, Co-founder and Chief Scientific Officer of Henlius, “In 2020, Hanquyou^®The company has successfully passed the EU GMP on-site inspections for both the drug substance and drug product lines, as well as China’s GMP compliance on-site inspection, thereby obtaining internationally recognized quality certifications. This achievement stems from the internationalization strategy established at the very beginning of product development. Although domestic guidelines for biopharmaceutical development had not yet been formulated at that time, we were firmly committed to creating a product of international quality developed by Chinese innovators. This foundation paved the way for the approval and market launch of Hanquyou® in both China and Europe.

Hanquyou^®Professor Xu Binghe, Principal Investigator of the international multicenter Phase 3 clinical study and Director of the National New Drug (Anti-tumor) Clinical Research Center at the Cancer Hospital, Chinese Academy of Medical Sciences, stated: “HLX02 Hanquyou^®As the first biosimilar in China to conduct an international, multicenter Phase 3 clinical trial and also the first to submit a marketing authorization application in the European Union that was accepted for review, its approval for market launch is worthy of celebration. The Phase 3 clinical trial of Hanquyou® (HLX02) enrolled a total of 649 patients with previously untreated HER2-positive recurrent or metastatic breast cancer from 89 study centers across China, the Philippines, Poland, and Ukraine. The study results met the prespecified primary endpoint and multiple secondary endpoints, confirming that there are no clinically meaningful differences between HLX02 and the EU-marketed originator trastuzumab in terms of efficacy and safety. We look forward to Hanquyou^®Its market launch provides new treatment options for HER2-positive patients in China and the European Union, benefiting more cancer patients worldwide.”

To meet the global demand for high-quality, affordable medicines, Henlius has proactively targeted Hanquyou^®Has rolled out its commercialization strategy in both domestic and international markets. For the Chinese market, Henlius has completed the formulation of its commercialization strategy and established its core commercial management team, with comprehensive coverage across more than 260 cities within six major sales regions nationwide. On August 24, just ten days after receiving approval, Hanquyou® (EU trade name: Zercepac^®) The first prescription was issued simultaneously at multiple hospitals, officially entering clinical application and marking the launch of Hanquyou^®marking the beginning of benefits for HER2-positive patients in China. In addition, Henlius is actively building an international commercial operation network and has entered into a business cooperation with the global pharmaceutical company Accord, with Accord responsible for Hanquyou^®Regarding commercialization in Europe, the company’s first EU order has been delivered to Accord’s manufacturing site in the UK. Henlius has also established collaborations with leading international biopharmaceutical companies such as Cipla and mAbxience, continuously advancing the global rollout of Hanquyou.^®commercialization process, cumulatively covering more than 80 countries and regions worldwide.

Dr. Liu Shigao, Co-founder and Chief Executive Officer of Henlius, introduced: “Hanquyou^®This successful approval in the European Union is attributable to the Company’s forward-looking international strategy and extensive resources. We aim to fulfill our mission of benefiting patients worldwide by continuously driving our products into international markets, thereby redefining “Made in China.” In addition to Hanquyou®^®In addition, the multiple pivotal clinical trials currently being actively advanced by Henlius are all international multi-center clinical trials. While accelerating its commercialization process, the Company will continue to focus on product and technological innovation, pursuing a dual-pronged strategy to steadily align with its mission and vision, and striving tirelessly to become the world’s most trusted and admired biopharmaceutical company.”

China is a country with a high incidence of breast cancer and gastric cancer. The latest national cancer statistics released in 2019 show that breast cancer is the leading malignant tumor among women, with approximately 304,000 new cases.^[1], of which 20%–25% are HER2-positive patients^[2]; Gastric cancer ranks second among malignant tumors in China, with approximately 403,000 new cases.^[3], with a HER2 positivity rate of 3.7%–20.2%^[4]To benefit more HER2-positive patients and enhance the prevention, diagnosis, and treatment of HER2-positive breast and gastric cancers, Henlius officially launched the “Leave No HER2-Positive Patient Behind” public welfare initiative at this forum. By collaborating with multiple partners, including professional societies, the initiative aims to build an ecosystem of comprehensive solutions for the treatment of HER2-positive patients, forming an integrated healthcare ecosystem that effectively aligns patients and their families, physicians and medical institutions, pharmaceutical companies, health insurance providers, professional associations, and government agencies. The “Leave No HER2-Positive Patient Behind” public welfare initiative will integrate the capabilities and resources of all relevant stakeholders. Through cooperation spanning drug access, physician education, testing and diagnosis, patient management and education, patient payment solutions, and big data analytics, it seeks to streamline and optimize the entire industry chain for HER2-positive care, comprehensively improve the diagnosis and treatment standards for HER2-positive patients in China, maximize patient benefits, and achieve win-win outcomes for all parties involved.

Mr. Zhang Wenjie, President of Henlius, concluded: “Henlius is committed to serving patients worldwide with high-quality biologics. While building an industry-leading integrated biopharmaceutical platform and a global commercial footprint, we place greater emphasis on fundamentally improving disease diagnosis and treatment standards as well as drug accessibility. By actively collaborating with various stakeholders in the healthcare sector, we aim to construct a patient-centric health ecosystem that significantly enhances benefits for HER2-positive patients. We also look forward to welcoming more like-minded partners to join us in realizing the ambitious vision of ‘leaving no HER2-positive patient behind.’”

With Henquyout^®With the global launch and the initiation of the “Leave No HER2-Positive Patient Behind” public welfare program, Henlius has once again fulfilled its solemn commitment to cancer patients worldwide. Moving forward, Henlius will continue to uphold its core philosophy of “Affordable Innovation, Trusted Quality,” expand the international footprint of its product portfolio, deepen its expertise in oncology treatment, and actively promote the development of innovative biologics and manufacturing processes. By delivering high-quality innovative biologics to benefit more patients globally, Henlius aims to become the most trusted and admired innovative biopharmaceutical company worldwide.

Hanquyou^®(HLX02, EU trade name: Zercepac^®) is an injectable trastuzumab biosimilar independently developed and manufactured by Henlius in accordance with the biosimilar regulations of the European Union and China. It received marketing approval from the European Commission and the National Medical Products Administration in July and August 2020, respectively, becoming the first domestically produced monoclonal antibody biosimilar to gain dual approval in both China and Europe. Among them, Hanquyou^®Henlius and its partner Accord jointly drove the product’s market launch in the European Union, with Accord responsible for commercialization. The company’s first EU order has now been shipped from the factory and delivered to Accord’s production facility in the United Kingdom. Hanquyou^®In the domestic market, commercialization is driven by the company’s in-house commercial team. Just ten days after receiving formal marketing approval from the National Medical Products Administration (NMPA), Hanquyou^®The first prescriptions for Hanquyou were issued simultaneously at multiple hospitals, including Fudan University Shanghai Cancer Center and Zhongshan Hospital, Fudan University, marking its official entry into clinical application.^®(HLX02; EU trade name: Zercepac^®) The indications approved in China and Europe cover all indications of the originator trastuzumab, including: 1) HER2-positive early breast cancer; 2) HER2-positive metastatic breast cancer; 3) HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Breast cancer is the malignant tumor with the highest incidence and mortality rates among women, posing a serious threat to women's health worldwide. According to GLOBOCAN estimates, there are over 2 million new cases of breast cancer and more than 600,000 deaths globally each year. In patients with HER2-positive breast cancer, HER2 expression levels on the surface of tumor cells are higher than normal, accounting for approximately 25% of all breast cancer cases.^[1], is one of the major subtypes of breast cancer. HER2 (human epidermal growth factor receptor 2) is a receptor tyrosine kinase that promotes cell growth and proliferation. It serves as an important prognostic indicator for breast cancer patients and is a key predictive biomarker for anti-HER2 targeted therapy.^[2]Trastuzumab specifically binds to HER2, thereby inhibiting tumor cell growth, and simultaneously induces antibody-dependent cellular cytotoxicity (ADCC) to kill tumor cells. It has been recommended by domestic and international breast cancer diagnosis and treatment guidelines for use in all stages of therapy for patients with HER2-positive breast cancer, becoming the recognized “gold standard” medication for the full-course standardized treatment of HER2-positive breast cancer. In addition to breast cancer, HER2 overexpression is also commonly observed in gastric cancer or adenocarcinoma of the gastroesophageal junction. Approximately 22% of patients with metastatic gastric cancer are HER2-positive.^[3]. Trastuzumab in combination with chemotherapy can significantly reduce the risk of death and prolong overall survival in patients with HER2-positive metastatic gastric cancer, and has become the cornerstone of first-line treatment for this condition.

Henlius (2696.HK) is an international innovative biopharmaceutical company dedicated to providing high-quality, cost-effective innovative biologics to patients worldwide, with its product portfolio covering oncology, autoimmune diseases, and other therapeutic areas. Since its establishment in 2010, Henlius has built an integrated biopharmaceutical platform, with efficient and innovative core capabilities spanning the entire industry chain from R&D and manufacturing to commercial operations. The company operates R&D centers in Shanghai, China; Taipei, China; and California, USA. Its production and quality control systems adhere to international GMP standards, and its manufacturing base in Xuhui, Shanghai, has obtained GMP certification from both China and the European Union.

Henlius has proactively established a diversified, high-quality product pipeline comprising more than 20 innovative monoclonal antibodies, and is comprehensively advancing tumor immunotherapy combination regimens based on its proprietary anti-PD-1 monoclonal antibody, HLX10. To date, the company has successfully launched Hanlikang, the first biosimilar in China.^®(Rituximab), Hanquyou, the first domestically produced monoclonal antibody biosimilar approved in both China and Europe^®(Trastuzumab, EU trade name: Zercepac^®), the marketing application for HLX03 (adalimumab biosimilar) is under review and has been granted priority review status, with market launch expected this year. Meanwhile, more than 20 clinical trials are being conducted globally for 10 products and eight combination therapy regimens, and out-licensing agreements cover nearly 100 countries and regions worldwide.

[1] “2019 National Cancer Report”

[2] Clin Cancer Res. 2009 Dec 15; 15(24): 7479–7491.

[3] "2019 National Cancer Report"

[4] "Guidelines for HER2 Testing in Gastric Cancer (2016 Edition)"