Chia Tai Tianqing, Hausen, Hengrui...78 new drugs were approved for clinical use, Qilu biologics broke out, and influenza 1 new drugs struck

Wonderful content

Wonderful content

Class 1 new drug! The second domestic CAR-T product was approved;

Over 10 billion market! The sixth domestic PD-1 monoclonal antibody was approved;

The first company to report for production! Huadong Medicine attacked nearly $4 billion in large varieties;

Qilu biosimilar drugs are reported for production, and innovative drugs are approved for clinical use;

Healthy yuan exerts its strength, the first domestic inhaled antibiotic is reported for production;

The market is blank! Yuandong's first Class 1 biological drug was approved for clinical use;

Chia Tai Tianqing, Cinda.
.
.
30 new class 1 drugs were unveiled
.

10 new drugs are on the market! The second domestic CAR-T approved

10 new drugs are on the market! The second domestic CAR-T approved

From August 28th to September 10th, the approval/certification of the marketing application for 10 new drugs (13 acceptance numbers) was completed
.

Among the domestically produced new drugs, two category 1 new drugs were approved for marketing, namely WuXi Biologics/Yuheng Biologics' Sepalimab and WuXi Biologics' Regirenza; among the imported new drugs, Sanofi's Dupliyu New indications such as monoclonal antibody, Merck's pembrolizumab, and Bristol-Myers Squibb's nivolumab were approved

The listing applications of many new drugs have been withdrawn or disapproved, including Takeda's Vonolasen and Ferring Pharmaceuticals' Mesalazine
.

(8.
28-9.
10) New drug listing application review and approval status update

WuXi Giant Nuo's JWCAR029 (JWCAR029) is the second domestic CAR-T product and the sixth global CAR-T product, and it is also the first category 1 CAR-T product approved in China
.

Ruijilunzai is the first domestically approved CAR-T product targeting CD19, but Fosun Pharma’s 3.

Yuheng Bio/WuXi Biologics' Sepalimab is the sixth domestically produced PD-1 monoclonal antibody approved for marketing in China, and is used to treat relapsed or refractory classic Hodgkin's lymphoma above second-line
.

At present, 8 PD-1 monoclonal antibodies have been approved in China.

Two new indications for imported PD-1 monoclonal antibodies were approved.
Merck’s pembrolizumab won the eighth domestic indication for the first-line treatment of esophageal cancer.
The product will have a global sales revenue of 8.
078 billion U.
S.
dollars in H1 in 2021.
A year-on-year increase of 23%; Bristol-Myers Squibb’s nivolumab won the fourth domestic indication for gastric cancer first-line immunotherapy.
In 2021, H1 global sales revenue of this product was US$3.
630 billion, a year-on-year increase of 6%
.

Duplizumab was approved for the second indication for moderate to severe atopic dermatitis in adolescents and adults aged 12 years and above
.

This is a human-derived monoclonal antibody that targets IL-4Rα developed by Sanofi, which can block both IL-4 and IL-13 signaling pathways.

11 new drugs applied for listing! The first production of 2 blockbuster biosimilar drugs

11 new drugs applied for listing! The first production of 2 blockbuster biosimilar drugs

From August 28th to September 10th, 11 new drugs (17 acceptance numbers) listing applications were undertaken by CDE
.

Two blockbuster biosimilar drugs welcome the first production companies, namely Qilu's Disumab and East China's Liraglutide; Ginkgo/Yiling Wanzhou International's Class 1 new drugs Cerarevir and Servier's Atorvastatin, perindopril, amlodipine, and Langhua Pharmaceutical’s tilorizine, etc.

(8.
28-9.
10) Approved domestic/imported new drug listing application

Disulumab is a "first-in-class" anti-RANKL monoclonal antibody developed by Amgen, with global sales of approximately US$5 billion in 2020
.

In May 2019, it was approved to enter the domestic market.

Liraglutide is a human glucagon-like peptide 1 (GLP-1) analog developed by Novo Nordisk.
It has a variety of physiological functions such as promoting insulin secretion, protecting pancreatic β cells, delaying gastric emptying and reducing appetite.
Function
.

The product was first approved for listing in the United States in 2010, with global sales of 24.

Joincare's Tobramycin Inhalation Solution is a new type of antibacterial inhalation preparation developed in response to the high incidence of bronchiectasis and the lack of clinical drugs in China.
It is the first domestic inhaled antibiotic drug that has submitted a marketing application
.

According to data from Mi Nei.

Qilu, Hausen, CSPC.
.
.
78 new drugs approved for clinical use

Qilu, Hausen, CSPC.
.
.
78 new drugs approved for clinical use

From August 28th to September 10th, 78 new drugs (139 acceptance numbers) were granted implied approval for clinical trials
.
Among them, 51 varieties (87 acceptance numbers) are domestic new drugs, and 27 varieties (52 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 44 chemical drugs, 31 therapeutic biological products, and 3 Chinese patent medicines
.
Among the 51 domestic new drugs, 42 are Class 1 new drugs
.

(8.
28-9.
10) Approved clinically domestic/imported new drugs

Merck has 3 new drugs approved for clinical use
.
Belzutifan tablet is a new, potent and selective oral hypoxia-inducible factor (HIF-2α) inhibitor.
It is the first HIF-2α inhibitor approved by the FDA.
Its targeted signaling pathway related research was awarded in 2019 Nobel Prize in Physiology or Medicine; MK-1308A injection is a combined treatment plan of MK-1308 (CTLA-4 antibody) and pembrolizumab (PD-1 monoclonal antibody).
The highest domestic research and development progress has entered Phase II clinical trials for the treatment of advanced stages.
Hepatocellular carcinoma
.

Two dual antibodies of Pulmis have been approved for clinical use.
PM8001 injection is a PD-L1/TGF-β bispecific antibody, which is planned to be developed for advanced lung cancer.
The highest domestic research and development progress is already in phase I/IIa clinical research; PM1003 injection is a PD-L1/4-1BB bispecific antibody, which is intended to be developed for advanced malignant solid tumors.
This is the first clinical approval in China
.

The first clinically approved QLF31907 for injection is a bispecific antibody targeting programmed cell death-ligand 1 (PD-L1) and 4-1BB (CD137) independently developed by Qilu Pharmaceuticals.
The two-pronged approach enhances the effectiveness of anti-tumor drugs.

.
Qilu Pharmaceutical Biopharmaceuticals is welcoming a major outbreak.
Since 2021, 7 bio-innovative drugs have been declared for clinical use (6 for the first time).
Among them, QLS31905 (double antibody) for injection and QLS31901 (double antibody) for injection have started phase I clinical trials
.

Anti-Influenza Biologics ADC189 tablets are Cap-dependent endonuclease inhibitors.
By inhibiting the CAP structure-dependent endonuclease in influenza viruses, they are anti-influenza drugs with a new mechanism of action.
This is the first clinical approval.

.
Head-to-head research data shows that ADC189 has the advantages of no central nervous system side effects, oral absorption is not affected by food, and higher safe dosage compared with the same target control drug, showing the characteristics of "best-in-class"
.

The EP-9001A injection, which was first approved for clinical use, is the first class 1 biological drug independently developed by Youluo Biotech (a wholly-owned subsidiary of Yuandong Biology).
EP-9001A is a single drug targeting human nerve growth factor (NGF).
The cloned antibody selectively targets and binds to and inhibits NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action for other analgesics.
At present, no similar products have been approved for marketing at home and abroad
.

The first clinically approved JS014 injection is a recombinant interleukin 21 receptor (IL21) fusion protein introduced by Junshi Biologics for US$66.
5 million.
It is the first IL21/HSA fusion protein in China that can specifically bind to human IL with high affinity.
-21R and activate lymphocytes
.
There are 4 IL21-targeted products entering clinical development worldwide.
In addition to JS014, the two monoclonal antibodies ATR-107 (PF-05230900) and avizakimab (BOS161721) are in clinical phase I and phase II respectively; Amgen’s AMG256 It is a dual-function fusion protein of PD-1/IL21 and has started phase I clinical trials
.

AstraZeneca's first clinical approval, AZD5305, is a PARP1 selective inhibitor, which is expected to overcome the side effects of the listed PARP inhibitors, including intestinal toxicity or hematological toxicity
.
In the pre-clinical toxicology model, AZD5305 shows superior characteristics to olaparib, and the product is currently in phase I clinical trials abroad
.

RO7247669 is a bispecific antibody targeting PD-1 and LAG-3 developed by Roche.
LAG-3 and PD-1 mediate different signaling pathways, but may have a synergistic effect, leading to depletion of effector T cells
.
The product is undergoing phase I/II clinical trials worldwide, and this time it was approved for clinical use in China for the treatment of liver cancer for the first time
.

CP Tianqing, Haisco, Cinda.
.
.
42 clinical applications for new drugs were accepted

CP Tianqing, Haisco, Cinda.
.
.
42 clinical applications for new drugs were accepted

From August 28 to September 10, clinical applications for 42 new drugs (involving 57 acceptance numbers) were accepted by the CDE
.
Among them, 35 varieties (50 acceptance numbers) are domestic new drugs, and 7 varieties (7 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 19 chemical drugs, 20 therapeutic biological products, and 3 Chinese patent medicines
.
Among the 35 domestically produced new drugs, 30 are Class 1 new drugs
.

(8.
28-9.
10) Accepted clinical applications for domestic/imported new drugs

IBI397, which was first reported for clinical application in China, is the first SIRP-alpha inhibitor with a unique dual mechanism introduced by Cinda Biotech.
It has a differentiated mechanism and can provide immune activation signals and relieve immune suppression signals at the same time
.
At present, the product has not started clinical practice at home and abroad
.
Cinda has deployed 3 products for CD47-SIRPα, including CD47 monoclonal antibody IBI188 (letaplimab), PD-L1/CD47 double antibody IBI322 and SIRPα monoclonal antibody IBI397.

Dongyang Pharmaceutical's recombinant anti-PD-1 fully human monoclonal antibody injection is the second domestically declared PD-1 biosimilar drug, and it is presumed to be a nivolumab biosimilar drug
.
The first domestic PD-1 biosimilar to be declared for clinical use is Shandong Boan Biological's LY01015.
This product has been approved for clinical use
.

TPX-0022 capsule is an oral multi-target kinase inhibitor introduced by Zai Lab for over 360 million U.
S.
dollars.
Its new macrocyclic structure can inhibit the mutation of MET, CSF1R and SRC gene targets.
This is the first clinical application in China.
, The world's highest research and development progress is in phase I clinical
.

Data source: Minet database, CDE, company announcement
.
The data statistics period is from August 28th to September 10th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!

Data source: Minet database, CDE, company announcement
.
The data statistics period is from August 28th to September 10th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!