The introduction of new drugs for small cell lung cancer green leaf pharmaceutical has been approved clinically in China.

On August 27th china's State Drug Administration's Drug Review Center (CDE) announced that a clinical trial application submitted in China by Green leaf pharmaceutical company Lurbinectedin, an innovative anti-tumor drug licensed by PharmaMar, was approved for treatment of small cell lung cancer (SCLC) after the failure of first-line platinum-containing chemotherapy.
note that the drug was approved in the U.S. in June to treat adult patients with metastasis SCLC who are undergoing chemotherapy for platinum drugs or who develop the disease after chemotherapy.
the drug was approved clinically in China, meaning it is about to enter the clinical phase in China.
Screenshot Source: CDE.com Lurbinectedin is an inhibitor of RNA polymerase II that selectively inhibits not only the carcinogenic gene transcription process on which multiple tumors depend, but also the transcription process of tumor-related macrophages, as well as the production of cytokines that are critical to tumor growth.
, the drug was approved in the U.S. at an accelerated pace.
This approval is based primarily on open labeling, multi-center, single-arm clinical data for adult SCLC patients (including platinum-sensitive and drug-resistant patients) who developed the disease after chemotherapy with a lurbinectedin single drug.
results showed that the researchers assessed a total efficiency (ORR) of 35 per cent, a median mitigation duration (DoR) of 5.3 months, an independent review committee (IRC) of 30 per cent of ORR and a median DoR of 5.1 months.
addition to being approved in the United States, Lurbinectedin recently adopted a special access mechanism to give priority to patients in Australia and Singapore.
addition, the drug has been approved for use in the United States, the European Union, Switzerland and Australia for the treatment of small cell lung cancer orphans.
In April 2019, Greenlee Pharmaceuticals and PharmaMar reached an authorized research and development cooperation agreement, which granted Lurbinectedin exclusive rights to develop and commercialize all adaptations in China, including small cell lung cancer, and to require PharmaMar to transfer the drug's technology, which is produced by Greenlead Pharmaceuticals in China.
the approval of lurbinectedin in China means that the product is about to enter the clinical development phase in China.
is another recent development in the clinical development of Leafy Pharmaceuticals, after a new generation of NTRK inhibitors with independent intellectual property rights was accepted in China.
lung cancer is one of the most morbid and mortality cancers in the world, with small cell lung cancer being a more aggressive and difficult type of lung cancer, accounting for about 15% of all lung cancer patients.
past, systemic platinum-based chemotherapy was the main treatment for small cell lung cancer.
although small cell lung cancer is sensitive to platinum-based chemotherapy and the patient's remission rate can reach 50%-90%, recurrence and rapid progression are very common.
recent years, the emergence of new treatments has left patients with small cell lung cancer with more options.
addition to lurbinectedin, several PD-1 inhibitors have been approved worldwide to treat patients with small cell lung cancer.
addition, a number of new treatments for small cell lung cancer are under study, including RNA polymerase II inhibitors, CDK4/6 inhibitors, checkpoint inhibitors targeting TIGIT, Lag3, CTLA-4 and OX40, and more.
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