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Suzhou, China; Cambridge, Massachusetts, USA; and Rotterdam, Netherlands, February 26, 2021 /PRNewswire/ -- and Platinum Pharmaceuticals (stock code: 02142.HK) announced today that the National Drug Administration (NMPA) has approved its clinical trial application for developing an anti-CTLA-4 wholly human monoclonal heavy chain antibody HBM4003 and PD-1 antibody/chemotherapy to treat patients with advanced non-small cell lung cancer and other solid tumors. The clinical trial will evaluate the safety, tolerability, PK/PD, and initial efficacy of HBM4003 in combination with PD-1 antibodies and HBM4003, PD-1 antibodies, and chemotherapy in patients with advanced non-small cell lung cancer and other solid tumors. The main researcher of this project is Professor Lu Shun, chairman of the Lung Cancer Committee of the China Anti-Cancer Association, chief expert on key projects of the Ministry of Science and Technology, and director of the Department of Oncology at Shanghai Chest Hospital. Prior to that, Heplatin had obtained approval from the US Food and Drug Administration (FDA) for the HBM4003 IND declaration and the NMPA's IND application for HBM4003 single drug and another combination therapy, and successfully completed the administration of multiple patients in phase I clinical trials in Australia.
“HBM4003's approval for lung cancer clinical trials in China is an important step in its global development. “HBM4003 is a new generation of anti-CTLA-4 antibodies. Based on its unique mechanism of action, HBM4003 has shown good safety and strong anti-tumor activity in clinical studies.” Dr. Wang Jinsong, founder, chairman and CEO of Hebo Pharmaceuticals, said, “Lung cancer has always been the cancer with the highest incidence rate in the world, as well as the cancer with the highest mortality rate. According to the latest 2020 data, the number of newly diagnosed lung cancer patients worldwide is 2.2 million. The number of lung cancer patients in China exceeds one million. We expect HBM4003 to bring new treatment plans to the majority of lung cancer patients and benefit patients as soon as possible.”
regardingHBM4003
HBM4003It's resistantCTLA-4Whole-human monoclonal heavy chain antibodies, produced unique to Heplatinum Pharmaceuticals Harbour Mice®platform.HBM4003Shows enhancedADCC(antibody-dependent cytotoxic effects), highly expressed in the tumor microenvironmentCTLA-4 TregThe cells are extremely specific. Its potent anti-tumor effects, differentiated pharmacokinetic characteristics, and long-lasting efficacy show good product characteristics. This novel and differentiated mechanism of action has the potential to improve therapeutic efficacy and significantly reduce drug toxicity.
About Heplatinum Pharmaceuticals
Hebo Pharmaceutical (stock code: 02142.HK) is a global innovative biopharmaceutical company in the clinical development stage. The company focuses on innovative drug research and development for tumor immunity and immune diseases, and rapidly expands the innovative drug development pipeline through independent R&D, joint development and diversified cooperation models.
Heplatinum Pharmaceuticals used its two globally patented all-human antibody transgenic mouse platforms (H2L2 and HcaB) to develop all-human monoclonal antibodies and heavy chain antibodies, and created the HBiCE™ technology platform based on HCaB technology to develop dual-specific antibodies for immune cell linkers. At the same time, the company also authorizes technology platforms to other enterprises and academic institutions. Heplatinum Pharmaceuticals has carried out global operations in China, the United States, the Netherlands, etc.
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