Wanchun Pharmaceutical First In Class's new drug, Punabrin, has been recognized by the FDA as a breakthrough therapy.

On September 4th Beyond Spring announced that its New First-In-Class drug injection had been approved by the FDA as a breakthrough therapy for the prevention of chemotherapy-induced nucleocyte reduction (CIN) in non-myelin malignancies.
has previously been included in the proposed breakthrough therapy in China.
In just two days, Wanchun Pharma's own research and development of this drug has also reaped the breakthrough therapy in China and the United States, is expected to accelerate the market to become the first breakthrough treatment in 30 years in terms of severe CIN adaptive treatment standards and clinical benefits.
Wanchun Pharmaceuticals also said it would submit applications for the new drug to CDE and FDA, respectively, in the near future.
severe CIN (level 4 neutral granulocytosis) is the most serious hematological toxicity disease caused by chemotherapy drugs.
since 1991, only G-CSFs have been approved for the prevention of severe CINs.
But studies have shown that more than 83% of patients with some chemotherapy programs still have severe CIN even after G-CSF use, and that the lowest point of absolute neutral granulocyte count (ANC) usually occurs on day 6-8 (Note 1:Masuda, 2015), with clinical adverse consequences such as severe infection, fever, mycobacteremia and death.
, for patients undergoing high-risk chemotherapy, severe CIN must be prevented at the source to minimize the adverse clinical consequences of CIN.
30 years, this field has become an unresolved problem for medical workers all over the world.
Punabrin is a bird's ostrich nucleotide exchange factor (GEF-H1) activator, a non-G-CSF class drug, by reversing the blocking formation of neutrophils in the bone marrow induced by chemotherapy drugs, maintaining the neutral granulocyte level in the normal range, to achieve early protection of white blood cells in the bone marrow, to a different mechanism of G-CSF to reduce the occurrence of early CIN.
studies have shown that Punabrin prevents multiple severe CINs caused by chemotherapy drugs with different anti-tumor mechanisms.
Punabrin's breakthrough clinical significance lies in: First, Punabrin with its unique mechanism of action, rapid effective protection of the first 8 days of neutral granulocytes, and G-CSF time complement each other, significantly reduce the occurrence of non-myelin cancer patients due to chemotherapy caused by the full cycle of severe CIN, this is the first innovative breakthrough in 30 years of severe CIN treatment program.
II is an international multi-center Phase III clinical trial of PROTECTIVE-2 (106 Studies) for severe neutral granulocyte reduction (CIN) caused by Pnabrin for chemotherapy. The study endpoint "Percentage of no severe CIN in the first chemotherapy cycle" met the p-lt;0.01 standard, confirming that the combination therapy of Punablin and G-CSF was significantly superior to G-CSF single-drug therapy.
, with the percentage of non-occurrence of severe CIN as the main evaluation criteria, it is proposed to establish a new treatment standard for severe CIN, which is of clinical significance.
"We are pleased that both the National Drug Administration and the FDA have included Punabrin in the 'breakthrough therapy', which is a recognition of the clinical value of Punablin," said Dr. Huang Qi, CEO of Wanchun Brin.
we have been developing the innovative drug Punablin for 20 years, and the discovery of severe CIN adaptation is a breakthrough of nearly 4 years.
this milestone by integrating our various advantageous resources with between China and the United States.
this is a great recognition for Wanchun, representing our innovative First In Class drug into a full-scale accelerated market.
, we will advance the follow-up research of Punablin and the process of registration and commercialization of NDA in China and the United States. Du Lihua, general manager of
Wanchun Brin, added, "The breakthrough dual recognition of Punablin's efficacy by China's NMPA and the FDA is an encouragement to 60 research centers, more than 500 researchers and more than 100 project managers and operators from China, the United States and several European countries participating in this study."
This international multi-center II, III clinical research in 2017 was included in the national "13th Five-Year Plan" major new drug creation topics, is now fully promoting the registration of China and the United States NDA, through the identification of breakthrough therapies, Wanchun will get more efficient communication opportunities with NMPA and FDA reviewers, get guidance from the drug regulatory department, promote Punablin early listing in China, the United States, to bring the gospel to the vast number of patients! At present, Wanchun Pharma is actively promoting the Chinese and U.S. NDA reports of Punablin, which currently conducts four clinical studies, including three international multi-center clinical trials.
Currently, Wanchun is also actively promoting the international multi-center Phase III clinical study of Punabrin's treatment of non-small cell lung cancer (NSCLC), as well as the initiating of Prenablin's Phase I clinical trials for patients with PD-1/PD-L1 antibody therapy failure or disease progress.
is also the world's first immuno-small molecule drug to activate mature degenerate cells (DCs), and DC-based tumor immunoactivation therapy is expected to be the new cornerstone of immunotherapy in addition to PD-1/PD-L1.
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