First International Shipment of HANSIZHUANG

SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying HANSIZHUANG Zerpidio^® (anti-PD-1 monoclonal antibody, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of "benefiting patients worldwide with high-quality biopharmaceuticals", will arrive at the shipping warehouse near Pudong Airport and ultimately set sail for Indonesia. This shipment also opens a new chapter for HANSIZHUANG to benefit patients around the world.

Mr. Kurt Yu, Senior Vice President and Chief Commercial Officer of Henlius, said, "As the world's first and only anti-PD-1 mAb approved for small-cell lung cancer, the sooner HANSIZHUANG ventures beyond China and enters the global market, the earlier it can benefit more patients around the world. The overseas approval of HANSIZHUANG is yet one small step on its international journey. We completed the international shipment at full speed to Indonesia is a further demonstration of our dedication to 'Henlius Speed' and 'Patient-Centricity'."

On December 28, 2023, PT Kalbio Global Medika, the subsidiary of PT Kalbe Genexine Biologics (KGbio), the commercial partner of HANSIZHUANG in 10 ASEAN member countries, received the relevant registration certificates issued by Indonesia's National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the "BPOM") for the approval of HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio^® for the treatment of extensive stage small cell lung cancer (ES-SCLC), making it the first Chinese anti-PD-1 mAb approved in Southeast Asia. Since 2019, Henlius has been collaborating with KGbio to progressively expand collaboration in 22 emerging market countries across Southeast Asia, Middle East and North African (MENA) countries regarding HANSIZHUANG. The two parties are actively working towards obtaining approvals in more countries, aiming to bring advanced and efficient treatment options to local patients.

Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN 2020, there were near 35,000 new LC cases and 31,000 new deaths in Indonesia in 2020, and LC is still the leading cause of cancer death [1]. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases [2]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Around 30%–40% patients are in limited stage and most patients are in extensive stage when diagnosed [3]. Their clinical condition deteriorates rapidly, and the overall prognosis is poor. In the past 20 years, chemotherapy such as etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients in extensive stage relapse within one year [4]. The advent of immune checkpoint inhibitors has brought new hope to patients with SCLC. The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022 and became the world's first anti-PD-1 mAb for the first-line treatment of SCLC. The shipment of HANSIZHUNAG to Indonesia will bring new hope to local patients and increase their chances of survival.

At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting over 51,000 Chinese patients. In 2022, HANSIZHUANG 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 HANSIZHUANG to benefit from certain policy support for research and development, registration, and commercialisation in the United States (U.S.) and European Union. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare HANSIZHUANG 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.

Henlius has aggressively pursued international commercialization of HANSIZHUANG, actively collaborating with KGbio and other global partners to bring its therapeutics to patients in the United States, Europe, and other emerging markets, covering over 70 countries and regions. Through collaboration and innovation, Henlius will continue to contribute to the development and clinical application of immuno-oncology globally, providing more efficient and high-quality treatment choices for patients.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and Indonesia. Up to date, 4 indications are approved for marketing, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 3,700 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell, and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

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, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation center and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging.