SHANGHAI, Oct. 25, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in Europe has been dosed in the international multi-centre phase 3 clinical trial (NCT05353257) of the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination with chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) in EU country Latvia. The co-leading principal investigators are Jinming Yu, an Academician of the Chinese Academy of Engineering (CAE) and the Director of Shandong Cancer Hospital, Ligang Xing, the vice director of Shandong Cancer Hospital, and Ying Cheng, the Director of Jilin Cancer Hospital. Previously, the first patients in China, the U.S., Australia and other countries and regions have been dosed.
Shanghai, China, September 21st, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest results of two ADC (Antibody-drug Conjugate) products, HLX42, the novel EGFR-targeting ADC, and HLX43, the PD-L1 targeting ADC, will be published as posters at the 2023 European Society of Medical Oncology (ESMO) Congress in Madrid, Spain from October 20-24.
On September 11, 2023, the study results of ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), were released at the 2023 World Conference on Lung Cancer (“WCLC 2023”) hosted by the International Association for the Study of Lung Cancer. The results were orally presented by Professor Caicun Zhou from Shanghai Pulmonary Hospital, the leading principal investigator of ASTRUM-004.
Shanghai Henlius Biotech has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the international multicentre Phase III clinical trial of its pertuzumab biosimilar HLX11.
SHANGHAI, Sept. 28, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-005, an international multi-centre study led by Professor Ying Cheng, has been published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. ASTRUM-005 trial is a phase 3 study of HANSIZHUANG (serplulimab), an anti-PD-1 monoclonal antibody (mAb) developed by Henlius independently, plus chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). After Prof. Ying Cheng orally presented them at the 2022 ASCO annual meeting, the results of ASTRUM-005 attract wide attention among the global research community. And now, ASTRUM-005 makes its way to the international arena once again, demonstrating the high level of academic acclaim on a global scale, the intelligence of Chinese researchers, and the strength of Chinese pharmaceuticals in terms of independent innovation research and clinical development.
In a phase 1 clinical trial, the first human study of the pertuzumab biosimilar candidate HLX11(Shanghai Henlius Biotech), investigators found pharmacokinetic (PK) parameters, safety, and immunogenicity were similar to the US, EU, and China version of the reference product following a single dose in healthy male adults in China.
Shanghai Henlius Biotech, Inc. (2696.HK) announced that an international randomized phase 3 study (ASTRUM-005) of HANSIZHUANG (serplulimab), an...
SHANGHAI, April 7, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the first such designation granted to HANSIZHUANG. The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States. The company plans to file its NDA in China and MAA in the EU in 2022, making HANSIZHUANG potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC.
SHANGHAI, March 25, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments, providing an alternative treatment option for patients. Furthermore, it also empowers the domestic precision immunotherapy for tumors and promotes the high-quality development of China's biopharmaceutical industry.