"Pharmaceutical Curry Jun" Rongchang biological ADC new drug was accepted, Bayer anti-heart failure First-in-class new drug declared on the domestic market, chlorinated radon (223Ra) injection...

Read: Latest! Drug review dynamics at home and abroad! This week look at the point 1. International drug dynamics 2. Rongchang biological HER2 antibody joint drug Wedixito monoanti-anti-listing application was accepted 3.Bayer chlorinated radon (223Ra) injection China was approved for the treatment of prostate cancer 4. Anti-heart failure new drug vericiguat tablet domestic market application was accepted this period (August 21 to August 28) international and domestic market a number of new drugs approved.
Internationally, FDA approved the launch of Foundation Medicine's pan-tumor liquid biopsy products, Novartis' under-the-skin injection CD20 antibody treatment for multiple sclerosis was approved by the FDA, and Amgen CD38 antibody/protease inhibitor combination therapy was approved by the FDA.
Samsung's Beval pearl monobial-like drug Aybinitio approved by the European Union; AstraZeneta PD-L1 antibody drug Imfinzi approved in Japan for first-line treatment of widespread small cell lung cancer; Roche targets breast cancer new drug Kadcyla Approved in Japan, Roche's targeted anti-cancer drug Kadcyla New Indications was approved in Japan for complementary (postoperative) treatment for patients with HER2-positive early breast cancer (eBC) with residual immersive disease after new assisted (preoperative) treatment.
in China, NMPA new drug approval accelerated, a number of imported drugs have been accepted, more dynamics are as follows: domestic review and approval of the new dynamic this week CDE has 29 acceptance numbers (22 varieties) reported to the production status update, of which Bayer chlorinated radon injection was approved for the market, Qilu Pharmaceutical Peropani tablet status update, More developments are as follows: Bayer's chlorinated radon injection was approved for sale on August 27th, and Bayer Dofigo® (chlorinated radon s223Ra) injection was approved by the National Drug Administration to treat patients with despotic resistance prostate (CRPC) cancer with symptomatic bone metastasis and no known visceral metastasis.
Chlorinated palate (223Ra) injection is the world's first alpha-particle radiation radiotherapy drug, and the Critical Phase III ALSYMPCA study has demonstrated that Dofigo® survives significantly, is safe, and improves the quality of life (QoL) of patients, providing triple benefits to prostate cancer patients.
the therapy has previously been approved in more than 40 countries around the world, and in September 2019, the application for the listing of the chlorinated radon injection in China (acceptance number JXHS1900109) is to be included in the priority review.
cancer is the second most common malignant tumor in men, of which CRPC is the difficulty and focus of prostate cancer treatment.
are the most common areas of metastatic cancer in the body, and bone metastasis is particularly common in prostate cancer.
public data show that about 90 percent of patients with metastatic prostate cancer have bone metastasis.
metastasis has been shown to be the leading cause of morbidity and death in CRPC patients.
's ®, has opened up new drug options for prostate cancer patients.
Qilu pharmaceutical pythonpani tablet first generic is about to be approved drug intelligence data show that Qilu pharmaceutical submitted a new class 4 generic drug peropani tablet market application into the "in the approval" stage, is expected to be approved in the near future to become the drug's first domestic generic.
Pepani is a multi-target tyrosine inhibitor of vascular endothragm growth factors 1, 2 and 3, plate plate-derived growth factor alpha and beta, fibroblast growth factors-1 and -3, cytokine, leucocyte-mediate-2-induced T-cell kinase, white blood cell-specific protein tyrosine kinase, and transglobulin-derived tyrosine kinase.
, developed by GlaxoSmithKline and approved by the FDA in October 2009, is currently approved for allergies such as renal cell carcinoma and soft tissue sarcoma.
was approved in China in February 2017 for the treatment of renal cell carcinoma, and was subsequently included in the Medicare Category B list in the 2018 health care negotiations.
domestic review and approval of the new acceptance of this week's CDE new report production acceptance number 38, a total of 28 varieties, including Rongchang biological dixito monoantitor, Bayer vericiguat tablets and stone drug mitoleic lipid injections are of great concern, more dynamics see the table below: Rongchang biological HER2 antibody association drug On August 27th, the application for the listing of the Virdixito monoanti-anti-listing was accepted, and the application for the listing of a new drug for the treatment of patients with local late stage or metastatic gastric cancer (including gastroesophageal adenocarcinoma) developed by Rongchang Bio with the injection of the Virdixito monoantigen (commodity name: Edich ®) was formally accepted and is intended to be included in the priority review and approval process.
is the first self-developed antibody-drug association (ADC) drug in China to submit a new drug for market.
targeting the HER2 protein on the surface of the tumor,
precisely identifies and binds to cancer cells, penetrating the cell membrane into its interior, killing the cancer cells.
Clinical studies have shown that the treatment of her2-positive, including HER2 low expression (IHC 2 plus/FISH-) localized advanced or metastatic stomach cancer (including gastroesophageal combined adenocarcinoma) is significant, is a major breakthrough in the field of gastric cancer treatment.
of the anti-HER2 single-anti-resistance products currently approved for listing in China, China's independent research and development products also include Sansheng Guojian's injection with Inito monoanti and Fuhong Hanxuan's quto bead monoanti.
the injection of Initodan, a combination of chemotherapy to treat HER2-positive metastasis breast cancer, was approved in June this year.
Fuhong Hanxuan's curt-zhudan resistance was approved for domestic market in August for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and untreated HER2-positive metastatic gastric cancer or gastric/esophageal junction adenocarcinoma.
domestic listing application for the new anti-heart failure drug vericiguat tablets was accepted recently, and the domestic listing application for the new drug vericiguat tablets for Bayer heart failure was accepted by CDE.
, Bayer submitted a listing application for Vergiciguat in the European Union and Japan.
July 16, Vericiguat's U.S. listing application was accepted by the FDA and granted priority review eligibility, and the FDA is expected to respond with approval on January 20, 2021.
Vericiguat is a new oral soluble bird nucleotide cyclase (sGC) stimulant that targets the regulation of nitrogen oxide-soluble bird nucleotide cyclase-cyclophosphate bird glycoside (NO-SGC-cGMP) pathway, which can be used in a coalition with other heart failure treatments to reduce the risk of event deterioration, cardiovascular death and hospitalization of patients with reduced blood test scores (HFrEF).
application for Vericiguat is based on the first study of patients with symptomatic chronic heart failure who experienced a worsening heart failure event with a blood test score of less than 45 percent.
approved, it will be the first soluble bird nucleotide cyclase (sGC) astracite to treat patients with chronic heart failure.
stone drug mitoxine lipid body injection market application was accepted this week, stone pharmaceutical group 2.2 classes of new drug mitoxine lipid body injection market application was accepted by CDE, used in the past at least once received a first-line standard treatment of recurrence / incurable external T-cell lymphoma patients.
This new drug listing application is mainly based on baseline hydrochloric acid mittobenzene lipid body injections in regenerative cross-T cells and NK / T cell lymphoma single-arm, open, multi-center Phase II results.
the product is currently not available worldwide.
data sources: pharmaceutical intelligence data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, corporate announcements and other network public information.