(Yicai Global) Jan. 18 -- Henlius Biotech said its innovative anti-PD-1 monoclonal antibody drug Hansizhuang, in combination with chemotherapies carboplatin and etoposide, has been approved by Chinese regulators to treat extensive-stage small cell lung cancer.

Hansizhuang, whose generic name is serplulimab injection, is the world’s first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer, Shanghai-based Henlius Biotech announced late yesterday.

Hansizhuang received approval from the National Medical Products Administration mainly based on its phase three clinical studies in several countries, including China, Turkey, and Poland, the firm said. Trial results showed that the medial survival time of patients on serplulimab injection and chemotherapy was nearly 16 months, almost five months more than those in the placebo group.

“SCLC is the most aggressive subtype of lung cancer, patients with SCLC deteriorate rapidly in clinical behavior, and the overall prognosis is poor,” said Ying Cheng, lead principal investigator for the phase three trials. “The success of ASTRUM-005, a multi-center clinical trial of Hansizhuang, is a breakthrough in the treatment of ES-SCLC.”

Shares of Henlius Biotech [HKG: 2696] closed 1.7 percent higher at HKD15.34 (USD1.96) in Hong Kong today.

Early last year, the NMPA also approved the drug's use in treating microsatellite instability-high solid tumors and squamous non-small cell lung cancer, the firm said.

Lung cancer is one of the most common malignancies in the world, with 2.2 million new cases and 1.8 million deaths in 2020, according to the Global Cancer Observatory. Non-small cell lung cancer accounts for about 15 percent of all lung cancers globally, and it is known for its rapid progression, poor therapeutic effect, and short survival time.

Hansizhuang has completed the tender process on the procurement platforms of 28 Chinese provinces and was included in the commercial medical insurance directory of five cities, including Ningbo and Jinhua, benefiting more than 10,000 patients as of the end of 2022, Henlius Biotech added, noting that it plans to register the drug for marketing in the European Union and the United States.

Editors: Tang Shihua, Martin Kadiev