2 domestic 1 class of new drugs approved for listing! Novarthren Jianhua's first innovative drug is about to be approved

1. International drug dynamic 2. Two domestic 1 class of new drugs approved for market! 3. No cheng Jianhua's first innovative drug Abtini tablets will soon be approved 4. Hengrui Pharmaceutical Arkmos slow release capsule domestic first declared for listing This issue (December 11 to December 18) international and domestic review and approval of a number of products to make new progress.
internationally, Novartic's SiRNA therapy Leqvio (inclisiran) has been approved by the European Union for listing, Gilead Tecartus treatment for cytoblastoma has been approved by The European Conditional, and Mercadon Keytruda (Paboli pearl monoanti) colorectal cancer new adaptation has been recommended for approval by the European Union CHMP.
the innovative extrovirus treatment Klisyri, developed jointly by Athenex and Almirall, was approved by the FDA; Roche's multiple sclerosis drug Ocrevus was approved by the FDA; and GSK's Benlysta (belimumab) was approved by the FDA for extended adaptations to treat active lupus nephritis (LN) adult patients undergoing standard therapy.
In China, a number of new drugs, generic drug review and approval to make new progress, more dynamics are as follows: domestic review and approval of new dynamics this week CDE has 33 acceptance numbers (25 varieties) reported to the production status update, including No cheng Jianhua aboutini tablets, Hengrui pharmaceutical fluorine Pali capsules, Hesco Cyclophenol injections and Roche Edi osteophenol softgels have attracted much attention, with more developments as follows: Noshing Jianhua's first innovative drug abtinib tablets will be approved on December 14th, and The orelabrutinib tablet registration application enters the "in-approval" phase.
is expected to be approved in the near future, making it the third BTK inhibitor to be listed in the country, after Ibdini and Zebdini.
Auboutini is a highly targeted and selective new BTK inhibitor developed by Novarma, after Obudini's treatment of chronic lymphocytic leukemia/small lymphocyte lymphoma and set cell lymphoma was accepted by CDE and included in the priority review.
the status of the two listing applications to "in-process approval" means that Ebtini is expected to soon benefit both types of cancer patients.
drug intelligence data show that there are currently eight adaptations in the development stage, including relapsed refractic peripheral lymphoma, Fahrenheit globulinemia, central nervous system lymphoma and so on.
data source: Pharmaceutical Intelligence China Clinical Trial Database Two domestic 1 new drugs approved for market! Hengrui Pharmaceutical PARP inhibitors have been officially approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer, fallopian tube cancer or primary peritina cancer who have underwent second-line and above chemotherapy with embryoline BRCA mutation (gBRCAm).
, Hengrui Pharmaceuticals has seven innovative drugs approved for sale in China.
, the world's listed PARP inhibitors are mainly Olapali, Nirapali and so on.
and fluorine palpari is china's first independent research and development, with intellectual property patents PARP inhibitors.
, it is understood that after the listing, fluoroazolepali will continue to carry out clinical research in ovarian cancer maintenance treatment, pancreatic cancer, prostate cancer and other fields.
has been officially approved for use for sedation in endoscopy of the digestive tract.
the drug is an intravenous narcotic drug developed by Hesco over eight years with independent intellectual property rights and the company's first innovative drug product.
, HSK3486 is known to be a short-acting GABAA subject regulator, similar to the mechanism of action of propofol, but more effective and safe.
addition to this approved adaptation, Hesco is exploring the clinical study of HSK3486 for a variety of adaptations.
January 2020, HSK3486's new adaptation application for "general anaesthetic induction" was accepted by NMPA and was included in the priority review in February this year because of its clear therapeutic advantages.
Roche osteoporosis new drug Aedes aeoporosis softgel was approved for listing in China Recently, Roche's Japanese Chinese and foreign pharmaceutical co., Ltd. developed the Edi osteoporosis softgel (ED-71) was approved in China for the treatment of osteoporosis.
Edirol, an active vitamin D3 derivative, was launched in Japan in 2011.
March 2018, the application for the listing of a new drug in China for Edi bone alcohol softgels was accepted by CDE.
, according to an earlier press release issued by Sino-Japanese Pharmaceutical Co., Ltd., the application is based on the positive results of three key studies it conducted in China.
the study showed that Adi osteoporosis in the treatment of primary osteoporosis, the efficacy is better than alfa osteotisol, can significantly increase the density of bone minerals in patients, and the safety is similar to aphalphthalol.
Domestic review and approval of the new acceptance of this week's CDE new report production acceptance number 36, a total of 25 varieties, of which Hengrui Pharma Arkmos slow release capsules are of great concern, more dynamics see the table below: Hengrui Pharmaceuticals Thokmos slow release capsules the first domestic declaration listed on December 14, Hengrui Tekmos slow release capsules listed application was accepted by CDE.
at present, he kemos slow release agent type only the original research Astellas was approved for listing, no domestic generic drugs were approved, Hengrui for the first domestic declaration of "Tekmos slow release capsule" enterprises.
is a powerful immunosuppressant used to prevent organ rejection after liver, kidney, and heart transplantation, and to treat transplant rejection after liver or kidney transplantation that cannot be controlled by other immunosuppressive drugs.
2019 global sales of 12.1 billion yuan, according to the Company's Pharmaceutical Intelligence Data.
, it has capsules, ointments, injections, eye preparations and slow-release capsules approved for market, of which capsules and slow-release capsules have entered the health insurance category B directory.
Tekmos Global Sales Data (Source: Pharmaceutical Intelligence Global Best-Selling Drug Sales Data) Data Source: Pharmaceutical Intelligence Data, Corporate Announcements and Other Network Public Data Sources: Pharmaceutical Intelligence Network, Corporate Announcements and Other Network Public Information