政府新闻
印尼批准东南亚首个中国产PD-1抗癌药物 2024-01-02
Indonesia approves first China-made PD-1 cancer drug in Southeast Asia
Henlius Biotech's novel cancer treatment has become the first Chinese anti-PD-1 monoclonal antibody to be approved to be sold in Southeast Asia.
The Indonesian Food and Drug Authority gave the green light to use Serplulimab to treat late-stage small cell lung cancer, marking the first overseas entry for the medicine, the Shanghai-based drugmaker announced on December 28.
Serplulimab was first approved in China in March last year. Its scope of cancers has been widened to include non-small and small cell lung cancer, as well as esophageal squamous cell carcinoma. But clinical research continues to target other conditions too.
To expand overseas, Henlius granted Indonesian pharmaceutical firm PT Kalbe Genexine Biology the right to develop and commercialize Serplulimab in 10 members of the Association of Southeast Asian Nations in 2019. In August, it further enlarged the cooperation scope to 12 countries in the Middle East and North Africa, including Saudi Arabia, the United Arab Emirates, and Egypt, per the same source.
Chinese anti-PD-1 monoclonal antibodies are making breakthroughs abroad. Before Serplulimab, BeiGene got its Tislelizumab approved to be marketed in the European Union in September whereas Junshi Biosciences achieved a similar milestone in the United States in October.
Besides Europe and the US, Chinese pharma firms are starting to target Southeast Asia. Shanghai-based Junshi announced in March that it will set up a joint venture with Singapore's Rxilient Biotech to develop and commercialize Toripalimab in nine nations in Southeast Asia.
Source: Yicai Global
