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According to the announcement by the National Medical Products Administration (NMPA) on March 23, CStone’s RET inhibitor pralsetinib’s new drug listing application review and approval status has been updated to "Approval completed-pending certification", and the indication is Have previously received platinum-containing chemotherapy for transfection rearrangement (RET) fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The approval number is: National Medicine Standard HJ20210018.
This means that the drug has been officially approved.
Under the current background that no RET inhibitor has been approved for marketing in China, pratinib has filled this gap and has also become the first drug approved by CStone Pharmaceuticals.
RET is a proto-oncogene that rearranges during transformation and encodes cell membrane receptor tyrosine kinase.
Studies have shown that mutations, rearrangements, and deletions of RET gene are related to multiple endocrine adenomas, papillary thyroid cancer, and congenital tumors.
Hirschsprung's disease is closely related.
Pratinib is an oral, once-a-day, potent and highly selective RET inhibitor.
In preclinical studies, the drug consistently showed sub-nanomolar titers for the most common RET gene fusions, activating mutations, and predicted drug resistance mutations.
The product was originally designed by Blueprint Medicines Corporation based on its proprietary compound library, and CStone Pharmaceuticals obtained the exclusive authorization for the development and commercialization of the product in Greater China.
In 2020, Pratinib was approved by the U.
S.
FDA for three indications, namely, adult patients with metastatic RET fusion-positive non-small cell lung cancer confirmed by the FDA-approved test method, and 12 years old and above who require systemic treatment.
Adults and children with advanced or metastatic RET-mutated medullary thyroid cancer, as well as adults and children with advanced or metastatic RET fusion-positive thyroid cancer that require systemic treatment and are refractory to radioiodine (if applicable).CStone Pharmaceuticals announced in September 2020 that the new drug marketing application of pratinib for RET fusion-positive NSCLC treated with platinum-containing chemotherapy was accepted by the CDE and was subsequently included in the priority review range.
At the 21st World Conference on Lung Cancer (WCLC) online conference held at the beginning of this year, CStone Pharmaceuticals announced the results of pratinib in the global phase I/II ARROW pivotal study of Chinese patients in the form of an oral report.
As of May 22, 2020, this study included 32 Chinese patients with NSCLC with evaluable lesions who had previously received at least one platinum-based chemotherapy regimen.
After receiving 400 mg of pratinib once a day for 6 months, regardless of the patient’s RET fusion genotype, the overall disease control rate was 97%, and the objective response rate reached 56%, including 1 case of complete remission and 17 cases of partial remission The median time from medication to first remission for these 18 patients was 1.
9 months.
It is worth mentioning that CStone currently has three other drugs submitted for marketing applications, namely apotinib, avonib and suglimumab.
On March 5 this year, CStone Pharmaceuticals and Sinopharm Group signed a strategic cooperation agreement.
The two parties will work together to promote the commercialization of avatinib and pratinib after they are approved for listing in China.
End reference materials: [1] CStone Pharmaceuticals official website [2] Congratulations! China ushered in the first RET inhibitor! CStone's precision anti-cancer drug "Platinib" is approved [3] CStone's RET inhibitor "Platinib" is about to be approved [4] https:// /CJFDTotal-SHSW806.
007.
htm
The approval number is: National Medicine Standard HJ20210018.
This means that the drug has been officially approved.
Under the current background that no RET inhibitor has been approved for marketing in China, pratinib has filled this gap and has also become the first drug approved by CStone Pharmaceuticals.
RET is a proto-oncogene that rearranges during transformation and encodes cell membrane receptor tyrosine kinase.
Studies have shown that mutations, rearrangements, and deletions of RET gene are related to multiple endocrine adenomas, papillary thyroid cancer, and congenital tumors.
Hirschsprung's disease is closely related.
Pratinib is an oral, once-a-day, potent and highly selective RET inhibitor.
In preclinical studies, the drug consistently showed sub-nanomolar titers for the most common RET gene fusions, activating mutations, and predicted drug resistance mutations.
The product was originally designed by Blueprint Medicines Corporation based on its proprietary compound library, and CStone Pharmaceuticals obtained the exclusive authorization for the development and commercialization of the product in Greater China.
In 2020, Pratinib was approved by the U.
S.
FDA for three indications, namely, adult patients with metastatic RET fusion-positive non-small cell lung cancer confirmed by the FDA-approved test method, and 12 years old and above who require systemic treatment.
Adults and children with advanced or metastatic RET-mutated medullary thyroid cancer, as well as adults and children with advanced or metastatic RET fusion-positive thyroid cancer that require systemic treatment and are refractory to radioiodine (if applicable).CStone Pharmaceuticals announced in September 2020 that the new drug marketing application of pratinib for RET fusion-positive NSCLC treated with platinum-containing chemotherapy was accepted by the CDE and was subsequently included in the priority review range.
At the 21st World Conference on Lung Cancer (WCLC) online conference held at the beginning of this year, CStone Pharmaceuticals announced the results of pratinib in the global phase I/II ARROW pivotal study of Chinese patients in the form of an oral report.
As of May 22, 2020, this study included 32 Chinese patients with NSCLC with evaluable lesions who had previously received at least one platinum-based chemotherapy regimen.
After receiving 400 mg of pratinib once a day for 6 months, regardless of the patient’s RET fusion genotype, the overall disease control rate was 97%, and the objective response rate reached 56%, including 1 case of complete remission and 17 cases of partial remission The median time from medication to first remission for these 18 patients was 1.
9 months.
It is worth mentioning that CStone currently has three other drugs submitted for marketing applications, namely apotinib, avonib and suglimumab.
On March 5 this year, CStone Pharmaceuticals and Sinopharm Group signed a strategic cooperation agreement.
The two parties will work together to promote the commercialization of avatinib and pratinib after they are approved for listing in China.
End reference materials: [1] CStone Pharmaceuticals official website [2] Congratulations! China ushered in the first RET inhibitor! CStone's precision anti-cancer drug "Platinib" is approved [3] CStone's RET inhibitor "Platinib" is about to be approved [4] https:// /CJFDTotal-SHSW806.
007.
htm
