Dongyangguang Pharmaceutical, Qilu...59 new drugs were approved for clinical trials, Hengrui’s 11th category 1 new drug was submitted for production, and Amgen’s new drug struck

Wonderful content

The first domestic! Neuroblastoma targeted drug was approved for marketing;

New products continue, and the market for PD-1 monoclonal antibody over 10 billion is resurging;

In just six months, Amgen's US$2.

"Innovative Drug One Brother" 1.

Two Class 1 new drugs of Zhengda Tianqing and Cinda were approved for clinical use;

New anti-AD drug, the first domestic Tau antibody to apply for clinical application;

Kelun, Hausen, CSPC.

Progress of 14 new drugs on the market! New products in the over 10 billion market continue

During the period from August 7th to August 27th, the listing applications of 14 new drugs (23 acceptance numbers) had the review and approval status update

The marketing applications of a number of new drugs have been withdrawn or disapproved, including Osaikon’s 2.

In addition, the registration status of 5 drugs including Yuheng Pharmaceutical/WuXing Biologics' Sepalimumab, Bristol-Myers Squibb's Navulimab, Merck's Pembrolizumab, and Takeda's Vonolasen.

(8.

The market for PD-1 monoclonal antibody over tens of billions is resurging

Apomilast is a small molecule phosphodiesterase 4 (PDE-4) inhibitor developed by Xinji (acquired by Amgen).

BeiGene/EUSA Pharma's Datuximab β is a disialoganglioside (GD2) monoclonal antibody, and is the first FDA-approved drug specifically for the treatment of high-risk neuroblastoma in children

Green Cross/Tiger's recombinant human coagulation factor VIII belongs to the third generation of recombinant human coagulation factor VIII, which is used for the prevention and control of bleeding in patients with hemophilia A (≥12 years old)

6 new drugs apply for listing! New drugs introduced by Hengrui heavily invested in production

During the period from August 7th to August 27th, 6 new drugs (7 acceptance numbers) listing applications were undertaken by CDE

(8.

Purnabrin of Dalian Wanchun Bulin Medicine is a GEF-H1 activator, which belongs to the "First-in-Class" immune anti-tumor drug

Vitorasen is an antisense oligonucleotide drug developed by Japan New Drug Co.

A number of new drugs and new indications have been reported, including Eli Lilly’s Ramoxitumumab (IgG1 monoclonal antibody), which is expected to be indicated for second-line hepatocellular carcinoma; BeiGene’s Tilelizumab (PD-1 monoclonal antibody) ), the expected indication is the first-line treatment of nasopharyngeal cancer

Chia Tai Tianqing, Dongyang Sun Pharmaceutical, Qilu.
.
.
59 new drugs approved for clinical use

From August 7th to August 27th, 59 new drugs (94 acceptance numbers) received implied approval for clinical trials
.
Among them, 41 varieties (64 acceptance numbers) are domestic new drugs, and 18 varieties (30 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 29 chemical drugs, 29 therapeutic biological products, and 1 Chinese patent medicine
.
Among the 41 domestically produced new drugs, 31 are Class 1 new drugs
.

(8.
7-8.
27) Approved clinically domestic/imported new drugs

Hengrui Medicine has 7 new drugs approved clinically, including Class 1 new drug SHR-1701 injection, HRS6807 for injection, SHR-A1912 for injection, SHR-1901 injection, HRS2300 tablets, SHR-1314 injection and 2.
2 new drug HRG2010 Capsules
.
Two new drugs have not been clinically approved for the first time.
SHR-1701 injection is an anti-PD-L1/TGF-βRII bifunctional fusion protein.
The indications for advanced colorectal cancer are already in phase III clinical trials.
SHR-1314 injection is one of the IL-17A monoclonal antibody, an indication for moderate to severe chronic plaque psoriasis, is in phase III clinical trials
.

Innovent’s first clinically approved IBI325 is a CD73 monoclonal antibody.
Currently, there is no drug with the same target on the market.
In China, TJ004309 injection of TJ004309 is making the fastest progress, and the indications for advanced solid tumors are already underway.
Phase II clinical; IBI110, which is not approved for clinical use for the first time, is a recombinant fully human anti-LAG-3 monoclonal antibody that can synergize with PD-1/PD-L1 monoclonal antibody to improve the anti-tumor effect.
Its indications for small cell lung cancer are already available.
Carry out Phase II clinical trial
.

Pharmaceutical CTTQ paragraph 2 the first class of drugs approved clinical, respectively TQB3617 TQA3605 capsules and tablets, the former for the treatment of advanced cancer, which is used for the treatment of chronic
.

Dongyang Pharmaceutical’s HEC93077 tablet is a new class 1 anti-gout drug.
In the company's existing product line, there are already two anti-gout preparations, febuxostat tablets and benzbromarone tablets
.
Since the beginning of this year, Dongyang Pharmaceutical has been clinically approved for 6 new class 1 drugs, including HEC73077 tablets, HEC116094HCl·3H2O tablets, HEC88473 injection, frexidine tablets, ifenidone hydrochloride tablets and HEC93077 tablets
.

Chentai Medicine’s Zorifertinib tablets are a new generation of EGFR-TKI specially designed for patients with advanced non-small cell lung cancer with central nervous system metastasis.
Achieve a drug concentration similar to that in plasma
.

BBM-H901 injection is a letter to a pharmaceutical research and development of adeno-associated virus (AAV) gene therapy, the clinical approval for the first time, for the prevention of bleeding in hemophilia B patients with adult males
.
This product is a systemic gene therapy for rare diseases and is the first AAV gene therapy drug approved for clinical hemophilia in China
.

QL1706 injection is a PD-1/CTLA-4 bispecific antibody developed by Qilu Pharmaceutical.
This is a new indication that has been approved for clinical use.
It is combined with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma and its advanced liver cancer.
The indications of has been carried out in the domestic phase I clinical
.

Palovarotene capsule is a new and selective retinoic acid receptor gamma (RAR gamma) agonist obtained by Ipsen’s acquisition of Clementia for over 1.
3 billion US dollars.
Various diseases such as osteochondroma (MO) and dry eye have been approved for clinical use for the first time in China this time for the prevention of heterotopic ossification in adults and children with FOP
.

JSI-1187 capsule is an oral, highly selective ERK1 and ERK2 small molecule kinase inhibitor independently developed by JSI.
Targeting ERK kinase is a promising tumor treatment strategy for the treatment of multiple ERK pathway mutations
.
JSI-1187 is mainly used for precision treatment of malignant solid tumors with mutations in the MAPK kinase pathway.
It is currently undergoing phase I clinical trials in the United States
.

Nipocalimab injection is an anti-FcRn antibody obtained from Johnson & Johnson's acquisition of Momenta for approximately US$6.
5 billion.
It is intended to be developed to treat systemic myasthenia gravis and has the potential to become a "best-in-class" anti-FcRn therapeutic drug
.

CSPC, Hausen, Kelun.
.
.
104 new drug clinical applications were accepted

From August 7 to August 27, clinical applications for 104 new drugs (involving 152 acceptance numbers) were accepted by the CDE
.
Among them, 77 varieties (118 acceptance numbers) are domestic new drugs, and 27 varieties (34 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 50 chemical drugs, 52 therapeutic biological products, and 2 Chinese patent medicines
.
Among 66 domestically produced new drugs, 56 are Class 1 new drugs
.

(8.
7-8.
27) Accepted clinical applications for domestic/imported new drugs

Hengrui Medicine has applied for clinical application of 10 class 1 new drugs.
HRS-8080 tablets, SHR-A1921 and HRS9531 injection for injection are the first clinical applications, and there is no detailed information on the target
.

9MW2821 is an innovative ADC drug targeting Nectin-4 developed by Maiwei Biology.
It has the advantages of uniform structure, high purity, and ease of industrialization.
It is the first domestic drug with the same target to enter the IND
.

Nuocheng Jianhua’s ICP-189 tablet is a potent oral SHP2 allosteric inhibitor with the potential to become a broad-spectrum anti-cancer drug
.
At present, there is no drug with the same target on the market in the world.
There are 8 domestic companies dedicated to the development of this target drug.
Among them, JAB-3068 jointly developed by Jacos and AbbVie has the fastest progress, and the indications for advanced solid tumors are under development.
Phase clinical
.

Biotech’s BAT7104 injection was submitted for the first time in China for clinical application.
This is a PD-L1/CD47 bispecific antibody designed to inhibit PD-1/PD-L1 and CD47/SIRP-α pathways
.
Since the beginning of this year, Biotech has promoted the development of a variety of antibodies, including the biosimilar drug BAT2306, OX40 monoclonal antibody BAT6026, and two TIGIT monoclonal antibodies BAT6021 and BAT6005.
These four monoclonal antibodies have been approved for clinical use; HER2 monoclonal antibody The two monoclonal antibodies, BAT1006 and CTLA4 monoclonal antibody BAT4706, are advanced to phase I clinical trials
.

The first clinical application of ADG126 injection in China is a new type of anti-CTLA-4 fully human IgG1 antibody independently developed by Tianyan Pharmaceutical through its artificial intelligence antibody discovery platform.
Compared with traditional antibodies, this product is expected to minimize Side effects and expand the treatment window
.
At present, ADG126 has carried out phase I clinical studies around the world for the treatment of advanced solid tumors
.

JNJ-63733657 injection is a microtubule-associated protein (Tau) antibody drug developed by Johnson & Johnson.
The world's highest research and development progress is phase II clinical for the treatment of Alzheimer's disease
.
At present, there is no drug with the same target in research in China
.
This is the first clinical application for this product in China .

Data source: Minet database, CDE, company announcement
.
The data statistics period is from August 7th to August 27th.
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!