On December 3, Ge Longhui │ Today, Henlius (2696.HK) announced that the innovative anti-PD-1 monoclonal antibody H drug, Hansstatus (generic name: sulilumab injection), independently developed by the company, has officially obtained approval from the National Medical Products Administration. Together with pembrolizumab and carboplatin, it is suitable for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer that is unresectable due to epidermal growth factor receptor gene mutation negativity and anaplastic lymphoma kinase negativity. This is the fifth indication approved for the H drug in China, and the third indication approved for the product in the field of lung cancer after squamous non-small cell lung cancer and extensive stage small cell lung cancer, potentially bringing more treatment options to many lung cancer patients. In the field of lung cancer, the company's clinical layout has fully covered the first-line treatment of lung cancer. In addition to the approved sqNSCLC, ES-SCLC, and nsNSCLC, the company is actively promoting an international multicenter Phase III clinical trial of H drug in combination with chemotherapy and synchronous radiotherapy as first-line treatment for limited stage small cell lung cancer (LS-SCLC) worldwide; and conducting a head-to-head bridging trial of H drug compared to first-line standard treatment atezolizumab for ES-SCLC in the United States, to further support the H drug's marketing application in the USA.
- Headlines
- Henlius H drug has been approved for a new indication, achieving significant breakthroughs in the field of lung cancer treatment.
复宏汉霖H药获批新适应症 肺癌治疗领域持续取得重大突破
Henlius H drug has been approved for a new indication, achieving significant breakthroughs in the field of lung cancer treatment.
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