The first domestic PARP inhibitor is about to be approved! The anaesthetic market is welcoming 1.1...

This issue (November 27 to December 04) monoantial drug declaration is still hot, a number of heavy new drugs reported new progress.
Internationally, the first new drug to treat obesity caused by specific genetic defects, Imcivree™, was approved by the FDA; the first oral hydrogenated pine particle agent, Alkindi Sprinkle, was released in the United States; the FDA approved the first anti-IgE antibody nasal diphtheria therapy; and the FDA approved the first PSMA targeted PET imaging drug for prostate cancer patients.
approved in Japan for the treatment of unstophectable hepatocellular carcinoma by Takeda Cabozantinib, and for the treatment of gangrene pus in Japan.
sanofi/regenerative dupixent has been approved by the European Union for the treatment of children with endexual dermatitis, and the Pfizer/BioNTech new crown vaccine BNT162b2 has been granted emergency use in the UK.
In China, a number of new drugs, generic drug review and approval made new progress, CDE again accepted a number of imported monoantigen drugs, more dynamics are as follows: domestic review and approval, new dynamic this week CDE has 51 acceptance numbers (37 varieties) reported production status updates, including Hengrui Pharmaceutical PARP inhibitor fluorine parli capsules, tadarauf and Hesco cyclophenols have attracted much attention, more dynamics as follows: the first domestic PARP inhibitor! Hengrui Class 1 new drug "Fluopali Capsules" will soon be approved drug intelligence data show that Hengrui Pharmaceutical Class 1 new drug "Fluorine Paley Capsules" market application to enter the administrative approval stage, is expected to be approved in recent days, the drug is the first domestic enterprises independently developed PARP inhibitors, used to treat patients with BRCA1/2 pathogenic or suspected pathogenic mutations after second-line and above chemotherapy.
, there are currently four PARP inhibitors on the market worldwide: Olapali, Lucapali, Nyrepali and Razopali.
Olapali and Nyrepali have been approved for domestic listing in 2018 and 2019, respectively, after cutting prices by 61.8% in the 2019 health care negotiations to enter Medicare Category B, which pays $169.00 (150mg/piece).
pharmaceutical data show that Leilapali's global sales in 2019 exceeded 11.3 billion yuan, and the trend is increasing year by year, the market potential is huge.
Domestic PARP Inhibitor Declaration (Data Source: Drug Registration and Acceptance Database) Hengrui submitted its application for the listing of fluorine palpari on October 29, 2019, and its listing application was included in the CDE's priority review approval on December 5.
application for the listing is based on a multi-center Ib study on the efficacy and safety of fluorine palladium in platinum-sensitive ovarian cancer with BRCA1/2 mutations, which was presented as a wall report at the 2019 ESMO Conference.
Currently, Hengrui has carried out 26 clinical trials for fluorine palladium, which involve small cell lung cancer, solid tumors, relapsed metastatic triple-yin breast cancer, prostate cancer, relapsed ovarian cancer, advanced stomach cancer, etc.
Hengrui Pharmaceuticals Tadalla non-tablets were approved for listing recently, Hengrui Pharmaceuticals 4 classes of generic drugs Tadalla non-tablets were approved for listing, and as if through consistent evaluation.
is used to treat the symptoms and signs of erectile dysfunction (ED) and its combined benign prostate hyperplosome (BPH).
the drug was first developed and marketed by Lilly ICOS (a joint venture between Lilly and ICOS) and United Therapeutics, and is an orally effective phosphate dylsterase 5 inhibitor.
the drug is the second round of collection varieties, there are currently 9 enterprises in China with the new registration classification approved and as if through the consistent evaluation, 14 enterprises submitted applications for listing, and 21 enterprises are in the BE trial stage.
Haisco Class 1 new drug cyclophenol is about to be approved recently, Hesco's Class 1 new drug HSK3486 emulsion market application entered the approval status, will soon be approved for market.
expected to be approved this time for digestive endoscopy diagnosis and treatment of sedation and/or anesthesia.
HSK3486 (i.e., cyclophenol, the product named Sisshuning) is a new class 1.1 innovative drug developed by Hesco with independent intellectual property rights, is China's first intravenous drug innovation of autonomous compounds, intended for surgical whole hemp induction, endoscopic sedation/anesthesia, ICU sedation and other adaptations.
So far in 2020, five new drugs have been approved for the market in the 10 billion market, of which only two are new (Hengrui announced on January 3, 2020 that the injection of toluene sulfonate has been approved for listing), and if Hesco's HSK3486 emulsion is successfully approved, it is expected to become the third new class of drugs to be marketed this year.
Domestic review and review approval, new acceptance this week CDE new report production acceptance number 37, a total of 27 varieties, of which 100-time Meishi Shibonavuliyu single resistance and Ipimu single-resistance, Hengrui Majulun, Zhengda Tianqing injection with right rezoson and methyl sulfonate safamine tablets are of great concern, more dynamics see the table below: Hundred Times On December 3rd, Shiguibao filed a listing application for Opdivo and Yervoy's new adaptive disorders in China, and an application for the listing of new adaptations submitted by BMS for immuno-checkpoint inhibitors nivolumab, Opdivo and ipilimumab (Yervoy) was accepted.
And just a week ago, the combination therapy of the two new drugs was to be included in the priority review of "conditional approved drugs" for the treatment of non-extinct non-epithelial malignant thoracic mesothelioma adult patients with primary treatment.
, this is the first drug therapy approved for mesothelioma in 16 years, according to public information.
BMS submitted applications for the two new drugs at the same time, speculating that it could be a combination therapy for two new drugs.
is a PD-1 inhibitor that helps the body restore its anti-tumor immune response by harnessing the body's own immune system.
the product has been approved worldwide to treat advanced melanoma, lung cancer, renal cell carcinoma, Hodgkin's lymphoma and more than a dozen other adaptations.
in China, Navuliyu monoantigen was first approved for listing in 2018, and is currently approved in China for non-small cell lung cancer, head and neck squamous cell carcinoma, stomach/gastroesophageal connecting adenocarcinoma patients.
is a CTLA-4 inhibitor.
as one of the main negative regulatory factors of T-cell reaction, CTLA-4 antibody enhances tumor killing ability by enhancing T-cell activity.
the product was approved by the FDA in 2011 for the treatment of advanced melanoma, the world's first approved CTLA-4 antibody drug.
in China, Ipsui has submitted an application for the listing of a new drug by the end of 2019, which is currently under review and approval.
the 3rd Adaptive Report of Hengrui Rui Ma Lun was listed recently, Hengrui submitted the application for the listing of the new adaptive disease with toluene sulfonate rematron was accepted by CDE.
clinical trials currently under way, the new adaptations listed in this newspaper may be general anaesthetic.
is a short-acting GABAa-receiving astrogen designed by GSK and developed by Paion AG.
because of the instability of the free alkali of Remazolun, Paion developed it as a benzoate of Remazolun.
and Hengrui Pharmaceuticals selected less toxic toluene sulfonate into salts during the salt screening process.
March 2018, applications for the listing of toluene for gastroscopy sedative sedatives were accepted by the CDE and subsequently included in the priority review.
December 2019, the adaptation of toluazoleon to gastroscopy for gastroscopy was officially approved by the NMPA, the trade name Ripinen.
June 24, 2020, a second adaptive disorder of toluene sulfonate was approved for colonoscopy sedation.
addition, two other clinical applications for adaptive disorders, ICU mechanical anaesthetic sedation, and sedation before, during and during non-intive anaesthetic surgery, were approved.
it is worth mentioning that in this year's health care negotiations, Hengrui's toluene sulfonate remazolun and man-fu's methyl sulfonate remazolun have passed the formal review and are now in the negotiation stage.
success of the health care negotiations and the price reduction will have a significant impact on the follow-up competitive landscape of the species, the successful negotiations will be better access to hospitals, conducive to the rapid expansion of its market.
Zhengda Tianqing two Class 3 generic drugs declared for market injection with right Rezosom is Rezosom's d-isomer, is currently clinically recognized as the only drug used to prevent cardiac toxicity of the ring drug.
the drug was first developed by Chiron in the United States, first listed in Italy in 1992, approved by the FDA in July 1995, and then in Europe, Asia, Africa and other countries.
, injecting right-hand rezos has been included in the National Health Insurance Category B directory.
public data show that in 2019, the domestic public medical institutions terminal sales of more than 700 million yuan, and the market size is still growing year by year.
, Osaikang's right Rezosan is the only approved exclusive variety in the country, but has not yet passed the consistent evaluation.
addition, there are four domestic listing applications under review, the other two are GlandPharma/Fosun Pharmaceuticals declared imported generic drugs and Fosun Pharmaceuticals subsidiary Kaimao Bio-declared Class 3 generic drugs.
methadonate shamphetamine tablets are highly selective and reversible third-generation monoamine oxidase B (MAO-B) inhibitors with both dopamine and non-dopamine mechanisms for the treatment of Parkinson's disease.
At present, only Nanjing Zhengtianqing's safinamide was first reported for listing, 3 enterprises are in clinical trials, including Yangzijiang Pharmaceuticals and Ruiyang Pharmaceuticals, which have initiated BE trials, and Hainan Zanbang Pharmaceuticals, which is in Phase III clinical, and 3 other enterprises, such as Shi Pharmaceutical Group, have been approved for clinical trials.
data sources: pharmaceutical intelligence data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, enterprise announcements and other network public information