Analysis of the bright spots of new drugs approved in China in the third quarter of 2020.

The third quarter of 2020 has ended.
the third quarter of this year, China's State Drug Administration (NMPA) approved 25 new drugs, including new adaptations, and two biosypolitic drugs were approved, according to incomplete statistics.
, there were a number of bright spots in the quarter when new drugs were approved.
not only a record number of products, but also a number of "firsts" in specific product categories, such as the world's first α-particle radiation radiotherapy drug.
In addition, the new drugs approved in the quarter were highly rewarding in rare disease areas, such as the Fabre disease treatment drug agagaglyzyme α infused with a strong solution, the treatment of Hunter syndrome, such as Adothionase β injections.
new drugs approved in the third quarter of this year, the NMPA approved at least 25 new drugs, including new adaptations, has reached a new high.
at least 17 new drugs, including new allergies, were approved for listing in China in the first quarter, up from 22 in the second quarter, according to public data.
of the 25 new drugs approved in the third quarter, the majority were chemicals (20) and most were imported products (21).
Such as the world's first α-particle radiation radiotherapy drug, chlorinated radon 223Ra, from Bayer, was approved in China in August this year to treat patients with despotic resistant prostate cancer (CRPC) with symptomatic bone metastasis and no known visceral metastasis.
Again, as Pfizer's new phosphate dylsterase 4 (PDE-4) inhibitor Creboro ointment has been approved in China for use in patients with specific dermatitis, the approval makes it the first and only prescription drug in China for the treatment of mild and moderate specific dermatitis in children and adults 2 years of age and older.
From the field of drug treatment, in our statistics of these 25 new drugs, anti-tumor drugs (6) the most, endocrine system and metabolic drugs (4), in addition to immune system drugs, and treatment of hepatitis C, AIDS and other anti-infective drugs each 3 approved.
specifically, the field of anti-tumor has Mundi Pharma anti-tumor folic acid-like material metabolic inhibitor Platsa injection approved for the first time for the treatment of recurring or refractic exome T-cell lymphoma (PTCL); Janssen pharmaceutical next-generation androgen inhibitor A Patamine tablets were approved for new adaptations for the treatment of metastatic endocrine therapy for sensitive prostate cancer (mHSPC) adult patients, and Roche beva bead monoantitic injections (avivitin) for new adaptations for the treatment of adult relapsed glioblastoma (GBM) patients, etc.
It's worth noting that in the field of anti-infective drugs, the new anti-AIDS drug compound developed by Gilead Sciences, Enqutabinotinofovir tablets (commodity name: Shufatai), received a new adaptation in August this year, which, according to a press release, became the first drug approved in China for pre-exposure HIV prevention in uninfected populations.
chinese pharmaceutical companies, such as Songli, First Sound Pharmaceuticals and Reding Pharmaceuticals, continued to make efforts in the third quarter of this year, with four new drugs brought in by china's local innovation companies.
It is worth mentioning that, in the area of biosynthetic drugs, the quarter also had the first approval of the injection of pyrethroid monoantigen and Xinda Bio's Adamo monoantigen injection, and the approval of a new adaptation of Adamu monoantitic disease - treatment of Crohn's disease.
of the new drugs approved in the quarter, the full oral hepatitis C treatment developed by Goliath, Ravidavi combined with Danorivee (commodity name: Xinlilai), was approved for sale at the end of July.
ravidave is the next generation of generic genotype NS5A inhibitors for hepatitis C NS5A targets, and Dano Riverivir is a next-generation NS3/4A protease inhibitor.
Phase 2/3 clinical trials have shown that the Ravidavi/Danorieve combined treatment has a cure rate (SVR12) of 99% in patients with non-hepatic cirrhosis genotype 1.
A new class 1 drug in the field of cerebrovascular disease developed by Synological Pharmaceuticals, Idala feng rightol injection with a thick solution (commodity name: Synu New) was also approved in China in July this year through a priority review process, with the ontology being a stroke patient.
This is a combination of Idalafon and right ol 4:1 ratio preparation, in which Idalafon is an efficient free-form sievenger and antioxidant, rightol is a new type of inflammatory inhibitor.
the application of multiple mechanisms of two components can significantly reduce the acute ischemic stroke caused by brain nerve damage.
In addition, the season also had the re-ding medicine PARP inhibitor Nirapali (commodity name: Erle) supplementary new drug market application approved for advanced epithelitis ovarian cancer, fallopian tube cancer or primary peritoneal cancer adult patients maintenance Treatment, as well as Yichang Renfu jointly developed with Germany's PAION company, the new benzodiazepine class 䓬 drug injection with benzoic acid remazolun (commodity name: Rema) through the priority review process approved in China for colonoscopy sedation.
new drugs approved in the third quarter in the field of rare diseases have also brought innovative treatments to patients with rare diseases, including Pratsa mentioned above.
approved for the product, exocyte T-cell lymphoma, is a rare and fast-growing non-Hodgkin's lymphoma.
Among them, the rare disease drug Senaigimin eye drops (commodity name: Ocyvi) brought by Dompé was approved in China during the quarter for the treatment of moderate or severe neurotrophic cornealitis (NK), a rare progressive eye disease that causes corneal scar formation and vision loss.
press release, this is the first product approved by Dongpei Pharmaceuticals in China.
the clinical need for the new foreign drug Agagase α injection from Takeda was approved by the NMPA in August this year for long-term enzyme replacement therapy for patients diagnosed with Fabre disease.
is a rare X-chain hereditary lysosome storage disease.
, according to a press release, this is the only human-based enzyme replacement therapy in China that provides long-term heart and kidney protection and slows the progression of the disease, improving the quality of life of patients and their families.
In addition, this quarter there was a recombinant GC Pharma developed recombinant Adu glycate-2-sulphate enzyme replacement therapy Adu sulfatease β injection, approved in early September this year to treat Hunter syndrome, a rare, disabling and even fatal genetic disease.
noted that Beihai Kangcheng signed a licensing agreement with GC Pharma in early 2019 to obtain an exclusive interest in the drug in Greater China.
reference materials: 1. China's State Drug Administration Government Service Portal. Retrieved Oct 8, 2020, press releases from companies and public sources: Pharmaceutical Mission Hills, follow medicinalcond.com WeChat Public No.