In August, these nine new drugs were included in the priority review from Reding Pharmaceuticals, Mercadon...

Transfer from As of August 31, a total of 11 drug listing applications had been included in the priority review, involving nine innovative drugs from companies such as Reding Pharmaceuticals, Merca East (MSD), Keystone Pharmaceuticals and Rongchang Bio, according to information posted on the website of the Drug Review Center (CDE) of the State Drug Administration of China.
Divided according to the reasons for inclusion in the priority review, five of them are eligible for conditional approval, three are clinically urgently needed shortage drugs, innovative drugs for the prevention and treatment of diseases such as major infectious diseases and rare diseases and new modified drugs, and one is clinically in urgent need of rare diseases that have not been listed overseas.
1. Reding Pharmaceuticals: Ripretinib tablet drug action mechanism/target: Tyrosine kinase switch control inhibitor is included in the priority review reason: the qualified drug Ripretinib is a tyrosine kinase switch control inhibitor, by using a unique dual action mechanism to regulate kinase switches and active rings, thereby widely inhibiting KIT and PDGFR mutation alpha kinase.
, the product has been approved for listing in the US, Canada and Australia.
July, CDE accepted a new drug for ripretinib to be marketed for the treatment of adult patients with advanced gastrointestinal mesothelioma (GIST) who have been treated with three or more kinase inhibitors, including immatinib.
according to an international multi-center Phase 3 clinical study called INVICTUS, ripretin was used in 129 patients with advanced gastrointestinal mesothelioma who had previously been treated with treatments including imatini, Schoinini and rigoffini. The objective mitigation rate of ib was 9.4% (vs 0%), the total survival period was 15.1 months (vs 6.6 months) and the risk of death was reduced by 64% (risk ratio was 0.36).
2, Mercadon: Pabli pearl monoantigen drug action mechanism/target: PD-1 monoantitor inclusion priority review reason: eligible approved drug Pabli pearl monoantitor (Keytruda) was developed by Mercadon Heavy PD-1 inhibitors have previously been approved in China for 5 adaptations, involving melanoma, squamous/non-squamous NSCLC, PD-L1 positive NSCLC, and esophageal squamous cell carcinoma.
CDE's official website, the priority review is Keytruda's sixth listing application in China, which could be a first-line treatment for advanced hepatocellular carcinoma (HCC).
In a Phase 1b trial called KEYNOTE-524/study116, Keytruda combined oral polysuper tyrosine kinase inhibitor lenvatinib to achieve a clinically significant total remission rate for patients with non-removable advanced hepatocellular carcinoma who did not receive systematic treatment, with ORR reaching 36% and median DOR reaching 12.6 months.
3, Jia and Bio: Jeno monoantigen drug action mechanism/target: PD-1 monoantigen inclusion priority review reason: the qualified drug Geptanolimab is a targeted immunocell PD-1 humanized IgG4 monoclonal antibody, Jia and Bio have core intellectual property rights.
, Jeno monoantitors can be developed to treat a variety of advanced solid tumors by selectively blocking dual ligations (PD-L1 and PD-L2) to restore the immune system's ability to recognize and kill cancer cells.
this time, the product was included in the first new drug listing application (NDA) submitted in China for the treatment of relapsed or incurable external T-cell lymphoma (PTCL).
based on data from the One Arm Phase 2 Clinical Trials published this year by the American Association for Cancer Research (AACR), Jeno monotherapy recurrence and refractic weekly T-cell lymphoma have significant efficacy: IRC assessed ORR at 36.3 The main subtypes of PTCL benefited, with ALK-negative interstitiocyte lymphoma ORR reaching 58.3%, and 33.3% of the subjects who had previously failed Siddamine treatment were relieved.
4, North China Pharmaceuticals: Recombinant human-sourced anti-rabies monoantigen drug action mechanism/target: can directly and in vivo rabies into the priority review reasons: clinically urgent shortage of drugs, prevention and treatment of major infectious diseases and rare diseases and other diseases of innovative drugs and improved new drug recombinant human-sourced anti-rabies monoantivirus monoantitic injection (rhRIG) is North China Pharmaceutical Group's new drug research and development company independent innovation project, its mechanism of action and adaptation is: with the human rabies vaccine, to supplement the human rabies vaccine active immunity process antibody blank, can directly mediate the rabies virus in the body, play a passive immune role, used for rabies or other rabies virus susceptible animal bites, scratch patients passive immunity.
According to the North China Pharmaceutical Bulletin, the project in April this year obtained phase 3 clinical trial report, the conclusion is: recombinant human-sourced anti-rabies virus monoanti-injection combined with human rabies vaccine to class III suspected rabies exposure to the population after exposure to prevention to achieve the main efficacy and secondary efficacy endpoint, and good safety, to achieve the program objectives, experimental drugs are safe and effective.
5, Eddy Pharmaceuticals: ACC007 Drug Action Mechanism/Target: A whole new generation of non-nucleoside retrovirus inhibitors are included in the priority review reasons: clinically urgently needed shortage of drugs, innovative drugs to combat diseases such as major infectious diseases and rare diseases, and accredited new drug ACC007 is a new generation of non-nucleotide retrovirase inhibitors developed by Addie Pharmaceuticals to prevent viral replication and replication through non-competitive binding and inhibition of HIV retroviral enzymes.
because it does not bind significantly to central nervous system subjects, etc., it can significantly reduce adverse reactions to the central nervous system.
preclinical studies show that ACC007 is not resistant to drug resistance and has high in-body activity against wild HIV viruses and common drug-resistant mutant viruses.
same time, no liver and kidney toxicity were found in the study.
the first NDA submitted by Eddie Pharmaceuticals to be included in the priority review.
previously, the company had completed a Phase 3 clinical trial aimed primarily at demonstrating that the ACC007 trial group had a viral response (with a viral load of less than 50 copies per milliliter) at 48 weeks of treatment for HIV-infected persons without antiretroviral therapy.
results show that the results of the trial are good and have reached the main clinical endpoint target.
6, Real life: Azf-based drug action mechanism/target: HIV reverse transcriptase and auxiliary protein Vif dual-target inhibitors included in priority review reasons: clinically urgently needed shortage of drugs, innovations in the fight against diseases such as major infectious diseases and rare diseases The drug and the modified new drug Azf, a bio-developed HIV reverse transcriptase and auxiliary protein Vif dual-target inhibitor drug, are candidates for oral anti-HIV drugs, and this time the first NDA submitted by Real Biology has been included in the priority review.
according to the China Drug Clinical Trial Registration and Information Disclosure Platform, the company has registered seven clinical trials on the treatment of AIDS with Azf tablets, five of which have been completed and two of which are in progress.
According to a real biological press release, clinical studies have shown that the oral dose of Azfding is extremely small, and that the concentration of effective drugs (FNC-TP) in the target cells (exochemic blood monocytes) was still higher than that of half of the viruses after 5 days of administration.
low dose, multi-target, long-acting oral, and has the advantages of 100% inhibition of HIV replication more than 4 days after drug use.
7, Keystone Pharmaceuticals: Pralsetinib capsules Drug Action Mechanism/Target: RET Inhibitors Included in Priority Review Reasons: Conditionally Approved Drug Pralsetinib is one developed by Blueprint Pharmaceuticals A powerful, highly selective drug in the study of cancer-causing RET variants, including predictable drug-resistant mutations, is a daily oral precision therapy, and Keystone Pharmaceuticals was granted exclusive development and commercialization of the product in Greater China in 2018.
currently, pralsetinib has submitted multiple DAs in the United States to treat RET fusion-positive NSCLC, RET mutation-positive thyroid myelin cancer, and RET-positive thyroid cancer, and has been awarded FDA priority review eligibility and breakthrough therapy.
based on Keystone Pharmaceuticals' financial report for the first half of 2020, pralsetinib's registered studies in RET Fusion Positive NSCLC Chinese patients achieved the desired results, keystone Pharmaceuticals plans to submit a new drug application to CDE in the near future.
data showed that pralsetinib showed superior and long-lasting anti-tumor activity in patients with RET fusion-positive NSCLC with platinum-containing chemotherapy, and was well-to-resistant in the Chinese patient population.
8, Rongchang Biology: Injection with the anti-drug mechanism / target: target HER2 antibody association drug into the priority review reason: eligible for approval of the drug dixito monoanti (disitamab vedotin, RC48) is Rongchang biological development of antibody-drug association (ADC) drug.
the product targets her2 proteins on the surface of the tumor, which accurately identifies and binds to cancer cells, penetrating the cell membrane and entering its interior, killing the cancer cells.
. In the U.S., Wedixito monotherapy has also been approved by the FDA as an orphan drug for stomach cancer (used to treat rare diseases) and has been approved for Phase 2 clinical studies of urethra skin cancer.
the product submitted a listing application in China and received priority review, the adaptation is: for the treatment of local late stage or metastatic gastric cancer (including gastroesophageal adenocarcinoma).
According to the single-arm, multi-center critical Phase 2 clinical trial conducted by Rongchang Bio, 127 patients who had previously received chemotherapy of 2 or more lines of the system over-expression of advanced stomach cancer (including gastroesophageal adenocarcinoma), the IRC rated ORR at 23.6%, median PFS at 4.1 months, and median OS at 7.5 months.
9, Shandong Dr. Renfrida Pharmaceuticals: Butyl benzene tablet drug action mechanism / target: VMAT 2 inhibitors into the priority review reason: clinically urgent need for overseas marketed rare disease drug butylbenzene originally used for schizophrenia treatment, in 2008 was quickly approved by the U.S. FDA, becoming the first drug approved in the United States to treat Huntington's disease (HD).
The drug reduces the supply of monoamine compounds such as 5-serotonin, dopamine, and dethyrophetamine mainly by inhibiting the central nervous system's monoamine transporter protein 2 (VMAT 2) to produce pharmacological activity.
, according to the CDE announcement, the butyl benzene tablets included in the priority review are clinically in urgent need of overseas listed domestic unlisted rare disease drugs.
"dance symptoms" are the most visible symptoms of HD, with nearly 90 percent of Huntington's patients develop convulsions and involuntary movements that include upper and lower limbs, face or body during the illness.
, Huntington's disease had been included in the First Rare Diseases List in China.
note that the previous tablets developed by Teva have been officially approved in China.
References: China's State Drug Administration Drug Review Center. Retrieved Sep 3,2020, from the official websites and public press releases of the companies follow the WeChat Public Number of Pharmaceutical Mingkangde