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The Phase 2 IND Application of Henlius’ Novel Anti-HER2 mAb HLX22 Combined with Anti-PD-1 mAb HANSIZHUANG and HANQUYOU for the Treatment of HER2+ Gastric Cancer Approved by NMPA


Shanghai, China, October 28th, 2022-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for phase 2 clinical trial of HLX22,an anti-human epidermal growth factor receptor-2 (HER2) humanised monoclonal antibody (mAb) in combination with HANSIZHUANG (serplulimab) and HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®) and chemotherapy as the first-line treatment for HER2-positive locally advanced/metastatic gastric cancer (GC) has been approved by the National Medical Products Administration (NMPA).

Gastrointestinal tumours are high incidences malignant tumours in China, among which the newly diagnosed patients with gastric cancer in 2020 was about 478,500, only less than patients with colorectal cancer[1]. The prognosis of gastric cancer is generally not optimistic, especially for locally advanced and metastatic gastric cancer[2]. Although surgical resection provides effective debulking treatment for gastric cancer patients, patients with postoperative recurrence and metastasis have no chance of surgery, and the median overall  survival is short. As of now, trastuzumab combined with doublet chemotherapy has become the first-line standard treatment for patients with metastatic gastric cancer[3]. However, there is still room to improve the median progression-free survival based on above treatment[4]

HLX22 is an innovative anti-HER2 mAb introduced from AbClon, Inc. and further researched and developed by Henlius, indicated for the treatment of gastric cancer and breast cancer. HLX22 can also bind to HER2 subdomain at a different binding site from trastuzumab, which allows of simultaneous binding of HLX22 and trastuzumab to HER2. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 is well tolerated and has good safety profiles.

In recent years, with the in-depth research on immune-oncology therapy, anti-PD-1 mAb has made great progress in GC treatment, and related therapies have been recommended by authoritative cancer guidelines at home and abroad[3,5]. In addition, Henlius actively promotes combination immunotherapies based on self-developed anti-PD-1 mAb serplulimab, and the phase 3 clinical trial of serplulimab combined with chemotherapy as neoadjuvant/adjuvant therapy have been conducted for resectable GC. As for unresectable HER2-positive advanced GC, Henlius adds serplulimab to the targeted combination therapy of HLX22 and HANQUYOU, in order to investigate a more beneficial course of treatment for patients.

Up to now, Henlius has a well-established product pipeline in the area of anti-HER2 treatment. With the accumulated results and experience from extensive anti-HER2 research, the company has also built a solid foundation for discovering and developing anti-HER2 bispecific/innovative antibodies. The company will continue innovating and strive for breakthroughs to bring more affordable and quality biologics to patients around the globe.


HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®), a trastuzumab biosimilar, independently developed in accordance with biosimilar guidelines issued by the National Medical Products Administration (NMPA), the European Medicines Agency (EMA). HANQUYOU was successfully launched in China and Europe in 2020 for the treatment of HER2-positive breast cancer and gastric cancer. The company’s in-house commercial team responsible for sales and marketing of HANQUYOU in China market and its marketing planning lays a solid foundation for the sales growth. To date, HANQUYOU has benefited more than 70,000 patients in China. In August 2021, its 60mg specification was approved for marketing in China. Together with 50mg specification, HANQUYOU can flexibly meet the clinical medication needs of breast cancer patients with different body weights through more dosage forms and provide patients with personalized and more economical treatment plans. In addition, Henlius cooperates with Accord, Cipla, Mabxience, Eurofarma and Abbott to expand overseas markets and its licensed-out projects cover about 100 countries and regions, including the United States, Canada, Australia, Europe, and many emerging markets. Up to now, HANQUYOU has been launched in more than 30 countries, such as China, the United Kingdom (UK), France, Germany, Switzerland, and Australia.


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, 1 indication is approved for marketing in China, 3 NDAs have been accepted by the NMPA, and 11 clinical trials are ongoing across the world.

HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumours in March 2022 and 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 11 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 by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC, and the related clinical trial has also become the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designation by the FDA for treatment of SCLC.