60 new drugs approved clinically! Domestic class 1 new drugs exploded.

Medical Network September 28th Domestic 2nd! Thyda will take $6.5 billion in star-studded drugs; Haussen Pharmaceuticals Class 1 new hepatitis B drug declared on the market; $6.9 billion star anticoagulant Bayer brings new dosage form; New developments in two new Class 1 drugs, IND; Domestic 1 class of new drugs outbreak! 25 approved clinical cases; Huahai, stone medicine, Xinlitai 1 new drugs were approved clinically; Heng Rui, first voice... 18 domestic category 1 new drugs debuted.
5 new drugs are on the market! The $6.5 billion Star Drug Xinda will take over from September 12 to September 25, with five new drug (six acceptance numbers) being reviewed and approved for status updates.
Reding Pharmaceuticals' toluene sulfonate Nirapali capsules, Roche's Beva bead monoantigen injections were approved for new adaptations, Cinda Bio's Lytoxi monoantigen injections, Pfizer's chlorobenzene softgels, merck Sante's hydrochloric acid metformin tablet registration status changed to "in-approval."
(9.12-9.25) New drug listing application review status update Roche's Beva pearl monoantigen injection (avivitin) was approved for treatment in adult relapsed glioblastoma (GBM) patients.
glioblastoma is the most common and malignant primary intracranial tumor in adults, and the approval of the drug will bring new treatment options to patients with glioblastoma in China.
Avetin has been approved in China for combined chemotherapy for the treatment of metastatic colorectal cancer, as well as non-removable advanced, metastatic or relapsed non-squamous cell non-small cell lung cancer patients first-line treatment.
2019, Avitin's global sales were 7,073 million Swiss francs (about $7,115 million), up 4% year-on-year.
Rituxy monoantigen injection from Xinta Bio is Roche's Rituxan biosynthetic drug that will be used to treat non-Hodgkin's lymphoma (NHL).
is one of Roche's performance drivers, with Rituxan's global sales of CHF 6,477 million (approximately US$6,516 million) in 2019.
At present, only Fuhong Hanxuan and Cyntaf Bio have submitted applications for the listing of Lytoxi mono-anti-biosygenic drugs;
9 new drugs on the market! Between September 12th and September 25th, nine new drugs (24 acceptance numbers) were listed for CDE.
5 varieties (18 acceptance numbers) are imported new drugs and 4 varieties (6 acceptance numbers) are domestic new drugs.
in terms of drug types, 7 varieties (19 acceptance numbers) are chemicals and 2 varieties (5 acceptance numbers) are therapeutic biological products.
(9.12-9.25) was awarded the domestic/imported new drug listing application Bayer brought Devasaban's new dosage form Deva Saban particles.
Devasalban is a highly selective oral drug that directly inhibits the coagulation factor Xa, which inhibits the production of clotting enzymes and the formation of blood clots by inhibiting the endogenous and exogenous pathways of the clotting waterfall.
2019, devassalbans will have global sales of $6,934 million, according to Bayer and Johnson and Johnson.
phenol amine novove tablet (HS-10234 tablets) is a new class 1 drug developed by Howson Pharmaceuticals to treat chronic hepatitis B.
the new drug is a nucleoside reverse transcriptase inhibitor, very stable in plasma, is a new type of tynofovir pre-drug that can improve efficacy and reduce toxic side effects.
recently, amphenolamine nofowe tablets were included in the priority review on the grounds of "clinically urgently needed shortages of medicines, innovative and improved new drugs to combat diseases such as major infectious diseases and rare diseases".
Sovantinib is a new oral tyrosine kinase inhibitor developed by He Huang Pharmaceuticals, and an innovative oncology drug developed independently by Huang Pharmaceuticals, following the approval of the capsule, and submitted a new drug to the market in China.
application for the first new drug to be marketed in Sofantini was accepted by the State Drug Administration in November 2019 for the treatment of non-pancreatic neuroendocrine tumors and was included in the priority review in December 2019.
this time and Yellow Pharmaceuticals submitted a new drug market application for Sovantini to treat advanced pancreatic neuroendocrine tumors.
Ektini is the first small molecule with independent intellectual property rights to target anti-cancer drugs in China, which has been independently developed by Beda Pharmaceuticals.
Ektini has previously been approved for two adaptive disorders, the listing application for the new use of postoperative aids to treat adaptive disorders.
there is currently no approved EGFR-TKI targeted drug for postoperative ancillary therapy in patients with EGFR gene-sensitive mutation NSCLC.
intranet data show that in 2019, China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal Ektini sales of more than 1.5 billion yuan.
East Sunshine Medicine, Huahai, Xinlitai... Between September 12 and September 25, 60 new drugs (involving 92 acceptance numbers) were approved for clinical trials.
, 31 varieties (38 acceptance numbers) are domestic new drugs and 29 varieties (54 acceptance numbers) are imported new drugs.
from the drug type, there are 19 chemicals and 41 therapeutic biological products.
of the 31 domestically produced new drugs, 25 are class 1 innovative drugs.
(9.12-9.25) approved clinical domestic / imported new drug Dongsian drug has two new drugs approved clinical, respectively, HEC122505MsOH tablets, recombinant anti-VEGF humanized monoclonal antibody injection.
class 1 new drug HEC122505MsOH tablets are highly effective, highly selective MAO-B reversible inhibitors that are clinically intended to be used in the treatment of Parkinson's disease in lahgo.
2 new drug recombinant anti-VEGF humanized monoclonal antibody injection is an antibody drug targeting vascular endodermal growth factor (VEGF), is Roche's beva bead monoantigenic bio-analog drug.
HOT-1030 injection is a new class 1 drug from Huahai Pharmaceutical subsidiary Huabo Bio and Shanghai Huaotai.
HOT-1030 injection is a monoclonal antibody with CD137 (4-1BB) as its target and is intended to be used to treat advanced malignant solid tumors.
Up to now, CD137 (4-1BB) as the target of the drug has not been listed, the most cutting-edge research and development state is in the clinical phase II. Research phase, the main clinical use of adaptive disorders for solid tumors, chronic lymphocytic leukemia, non-Hodgkin lymphoma and so on.
ALMB-0168 is a similar first-in-class humanized monoclonal antibody atrial atrial atrial agent for the new target half-channel membrane protein Connexin 43, developed by AlaMab, a subsidiary of Stone Pharmaceutical Group, to treat major clinically-urgent diseases such as bone cancer, cancer bone metastasis and osteoporosis.
ALMB-0168 was awarded the FDA's Orphan Drug Eligibility and Rare Childhood Disease Qualification in 2019 for bone cancer, while a multi-center Phase I clinical trial is under way in Australia.
recombinant anti-IL-4R alpha humanized monoclonal antibody injection is a humanized anti-IL-4R alpha monoclonal antibody independently developed by Sansheng Guojian, with a brand-new amino acid sequence.
currently on the market worldwide, the IL-4R alpha target monoantigen is Sanofi's Dupixent, which was approved in China in June 2020.
2019, Dupixent's global sales were EUR 2,074 million, up 163.2% year-on-year, according to Sanofi.
All-human source anti-PD-L1 antibody injection (LDP) and recombinant anti-EGFR human mouse embedded monoclonal antibody injection (CDP1) is a therapeutic biological products independently developed by Guilin Sanjin Holding Sun Company Baobo Bio.
LDP is a class 1 new drug and CDP1 is a class 2.4 new drug, both of which will be used in the treatment of advanced malignancies.
Recombinant Human Neuromodulating Protein 1-Anti-HER3 Antibody Fusion Protein Injection (SAL007) is an independently developed NRG-1 (Neuromodulating Protein-1) fusion antibody drug developed by Salubris, a wholly owned company of Xinlitai.
the product, the first innovative biologic drug in the U.S.-China double report, was approved by fda clinical trials in the U.S. in February 2020 and is currently conducting human clinical trials in the U.S.
Fosun Pharma's injection daxibotulinumtoxinA (RT002) is a new generation of long-acting neurotoxin injection drugs developed by Revance in the United States, compared with the current commonly used botulinum toxin injection products, long-lasting is its greatest characteristic.
RT002 was approved for clinical adaptation to moderate to severe eyebrow tattoos, isolated neck dystia disorders.
similar products already on the market in China include type A botulinum toxin for injection, and Minanet data show that sales of type A botulinum toxin for end-use injection in public medical institutions in China in 2019 amounted to 313 million yuan, up 8.27 percent year-on-year.
it is worth mentioning that the clinical application for the new adaptation (upper and lower limb spasms) of type A botulinum toxin injections in Eljian has also been approved.
Hengrui, Reding, Tonghua Dongbao... Between September 12 and September 25, 47 clinical applications for new drugs (involving 77 acceptance numbers) were accepted by CDE contractors.
, 28 varieties (49 acceptance numbers) are domestic new drugs and 19 varieties (28 acceptance numbers) are imported new drugs.
from the drug type, there are 34 chemicals and 13 therapeutic biological products.
18 of the 28 domestically produced new drugs are among the first class of innovative drugs.
(9.12-9.25) is a palmic acid modified GLP-1 analogo with a class 1 new drug, Noliglutide Injection, which has been clinically applied for Hengrui Pharma. Through the modification of amino acid sequence, Noli glyco peptide not only ensures biological activity, but also enhances the ability to resist DEP-IV enzymatic solution, while palmic acid in the structure binds to serum protein, prolongs its half-life in the body, reduces the number of injections, and improves patient compliance.
Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) developed by Turing Point that is effective for ROS1 and TRK A/B/C and has therapeutic potential for patients who have not been treated with TKI or who have already used TKI.
in July, Redding Pharma reached an exclusive licensing agreement with Turing Point, and Redding Pharma was granted an exclusive license to develop and commercialize Repotrectinib in Greater China, with An advance payment of $25 million and potential milestone payments and royalties of up to $151 million.
Superspeed Insulin Injection (THDB0206) is a new generation of quick-acting insulin similars, and Tonghua Dongbao obtained exclusive clinical development, production and commercialization rights for this product in selected regions from Adocia, Germany.
only Noel and Nord's Fiasp and Lilly's Liumjev, which are currently available worldwide, have yet to be marketed in China.
THDB0206 was obtained through new preparation techniques based on the third generation of insulin-like agents (insulin injections).
the third generation of food-time insulin similar agents currently on the market in China mainly include lai insulin injection, mendon insulin injection and guly insulin injection.
class 1 new drug HEC95468 tablets intended to carry out adaptation for the treatment of pulmonary hypertension and anti-heart failure.
this year, Dongsian medicine has 6 new drugs submitted clinical applications, respectively, hydrochloric acid esphonoid tablets, toluene sulfonate ningerini capsules, HEC89736PTSA 0.5H2O tablets, HEC122505 MSOH tablets, HEC95468 tablets, recombinant anti-VEGF human-origin monoclonal antibody injection.
the first five of these drugs were class 1 new drugs, Ivnisterone and ningantinini for the first time declared clinical.
data sources: Mienet database, CDE, company announcement note: data statistics period of September 12 - September 25, according to the name of the drug statistics (excluding raw materials, preventive biological products, in-body diagnostic reagents), if there are omissions, welcome to point out!