And Huang China Pharmaceutical Technology Co., Ltd. ("and Yellow Pharma" or "Chi-Med") recently announced that it has begun rolling the submission to the U.S. Food and Drug Administration (FDA) of the first part of the new drug listing application (NDA) for the treatment of pancreas and non-pancreatic neuroendocrinoma (NET).
the company plans to complete the filing of new drug listing applications in the first half of 2021, which will be the first U.S. new drug listing application for He huang Pharmaceuticals.
surufatinib is a new oral tyrosine kinase inhibitor developed by He huang Pharmaceuticals, which has the dual activity of anti-angiogenesty and immunomodulation.
Sovantinib blocks tumor angiogenesic production by inhibiting endotranotrogen (VEGFR) and fibroblast growth factor subjects (FGFR) and inhibits the collection stimulation factor 1 subject (CSF-1R), which promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
's unique dual mechanism produces synergetic anti-tumor activity, making it ideal for use in combination with other immunotherapy therapies.
and Yellow Medicine currently have all the rights of Sovantinie worldwide.
in China, Sovantini has submitted two applications for the listing of two new drugs to treat neuroendocrine tumors (NET) :(1) non-pancreatic NET new drug market applications - based on positive results from SANET-ep III clinical trials, Accepted by the State Drug Administration in November 2019, included in the priority review in December 2019, and entered the "in-approval" phase on December 20, 2012, it is expected to be approved in the near future.
(2) Progress in the listing of new Pancreatic NET drugs - based on positive results from SANET-p III clinical trials, accepted by the National Drug Administration in September 2020.
U.S., the FDA's Fast Track Qualification (FTD) earlier this year allowed yellow medicine to submit applications for new drugs in batches on a rolling filing.
new drug listing application is based on two successful clinical studies of stage III neuroendocrine tumors in China, as well as data support for Sovantini's treatment of patients with non-pancreatic and pancreatic neuroendocrine tumors in the United States.
, and Yellow Pharmaceuticals reached an agreement with the FDA at a pre-NDA meeting prior to the announcement of the new drug's listing application, which could be used as a basis for filing a new drug listing application.
FDA will review the application and decide whether to accept it upon receipt of the full application.
based on scientific recommendations issued by the European Medicines Agency (EMA) Human Medicines Commission (CHMP) in August, the data will also be used as a basis for filing a listing permit application (MAA) with the EMA in 2021. Marek Kania, Managing Director and Chief Medical Officer of
and Yellow Pharmaceuticals International, said, "As our first new drug listing application in the U.S. begins, Huang Pharmaceuticals is further implementing its strategy of creating a global biopharmaceutical company that will bring innovative cancer therapies to patients around the world.
treatment of neuroendocrine tumors is in urgent need of new treatments, and Sovantini has shown significant clinical benefits in patients with advanced neuroendocrine tumors.
this filing with the FDA for the listing of new drugs marks an important step toward our goal of commercializing Sovantinib and other innovative therapies globally.
" surufatinib chemical structure (Photo: pubchem) and the Yellow Medicine Program launch an expanded course of treatment (Expanded Access Protocol) to ensure that patients with limited treatment options have access to this important treatment.
the FDA approves regulatory approval for the program, registration of early treatment programs is expected to begin in the first quarter of 2021.
FDA granted Sovantini 2 fast-track qualifications in April 2020 for the treatment of pancreatic and non-pancreatic neuroendocrine tumors, and orphan drugs in November 2019 for the treatment of pancreatic neuroendocrine tumors.
China Non-Pancreatic Neuroendocrine Tumor Research SANET-ep: This is a Phase III clinical trial in China for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (clinicaltrials.gov registration number NCT02588170).
the study successfully reached the pre-progressive lifetime (PFS) predetermed primary efficacy endpoint in the pre-planned medium-term analysis.
results showed that sovantinib reduced the risk of disease progression or death by 67%, the medium PFS in patients treated with sovantinib was significantly extended to 9.2 months, and in the placebo group it was 3.8 months (Risk ratio of 0.334;95% confidence interval of .223-0.499; p.lt;0.0001).
has an acceptable risk/benefit ratio for Sovantini.
SanET-p of China Pancreatic Neuroendocrine Tumor Research: Patients in the group were patients with low- or medium-level advanced pancreatic neuroendocrine tumors.
the study successfully reached the preset primary therapeutic endpoint of PFS in a preset interim analysis and terminated the study early (clinicaltrials.gov registration number NCT02589821).
results showed that Sovantinib helped reduce the patient's risk of disease progression or death by 51%, with a medium PFS of 10.9 months and a placebo of 3.7 months (HR 0.491; 95% CI: 0.391-0.755; p=0.0011).
safety of sovannzofantini is controllable and consistent with observations from previous studies.