Hengrui, Chia Tai Tianqing, Kangfang... 66 new drugs have been approved for clinical use!

Wonderful content

6.

The first domestic long-acting insulin/GLP-1 compound was approved;

$5 billion star medicine! BIOTEC and Dongyao sprint;

30 billion PPI drug market, domestically produced Class 1 new drugs are reported for production;

The new drugs of Zhengda Tianqing, Kangfang and Poinsettia were approved for clinical use;

"Innovative Drug One Brother" broke out! 12 new drugs and new developments;

Hausen, Dyne, Simcere.

13 new drugs are on the market in progress! Dongyang Sun Pharmaceutical, Microchip, Novo Nordisk.

Four domestic new drugs have been approved for production, including Chipglita Sodium Tablets, Dongyang Pharmaceutical's Insulin Glargine Injection, Tonghua Dongbao's Insulin Aspart Injection, and Youke Pharmaceutical's Cefotaxime Sodium for Injection Tazobactam sodium (6:1)

In addition, the evaluation results of Bevacizumab injection by Biotec and Toyo Pharmaceutical will be announced soon

(10.

Insulin glargine is a new type of insulin analogue with long-acting effect, no peak blood concentration, and smoothly lowering the blood sugar of patients.

Insulin aspart is a fast-acting analogue of human insulin.

Insulin deglulam/liraglutide injection is a long-acting basal insulin analogue insulin deglu and glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide compound preparation.

Microchip's Class 1 innovative drug sitaglipta sodium tablets is a peroxisome proliferator activated receptor (PPAR) full agonist.

Bevacizumab injection is a recombinant anti-human vascular endothelial growth factor humanized monoclonal antibody, which is a biological analogue of Avastin

12 new drugs applied for listing! Roche, Zhaoke, Sihuan.

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Anaprazole sodium enteric-coated tablets from Xuanzhu Biologics, a subsidiary of Sihuan Pharmaceutical, are a new generation of PPI inhibitors independently developed for the treatment of duodenal ulcers

Lepu Bio's Pratizumab is a differentially designed PD-1 antibody.
The S254T/V308P/N434A mutation is introduced into the Fc of IgG4 to extend the half-life
.
In July 2021, Putrizumab was first declared for marketing.
The indication is second-line melanoma.
The indication for this application is the treatment of satellite instability (MSI-H)/mismatch repair defect (dMMR) solid tumors
.
At present, 6 domestically produced PD-1 monoclonal antibodies have been approved for listing in the domestic market, and 3 PD-1 monoclonal antibodies are under review, including Genolizumab from Jiahe Biologics, Slulimumab from Henlius and Lepu Biologic's Putrizumab
.

Zhaoke Tumor's first gram Lizumab is a fully human anti-PD-L1 monoclonal antibody against tumor PD-L1 protein, which can release the "brake" of the immune system caused by tumor cells
.
Zhaoke Tumor's first gram Lizumab is the fifth PD-L1 reported for production in China, and it is also the first PD-L1 reported for second-line cervical cancer
.
Two PD-L1 monoclonal antibodies have been approved for marketing in China, including AstraZeneca’s duvalizumab (Imfinzi) and Roche’s atelizumab (Tecentriq); two PD-L1 monoclonal antibodies have been applied for listing In the trial, including Envolimab from Siddi/Corning Jerry, and Shugliimab from CStone Pharmaceuticals
.
According to data from Mi Nei.
com, the sales of terminal Valliumab in China's public medical institutions in 2021H1 exceeded 100 million yuan, a year-on-year increase of 353.
73%
.

Roche’s Entritinib capsule belongs to the first generation of TRK inhibitors.
It is used for NTRK fusion-positive locally advanced or metastatic solid tumors.
It is the FDA following Pembrolizumab (K drug) and Larotrectinib.
The third approved "broad-spectrum" anti-cancer drug
.
In May 2021, Bayer's Larotrectinib sulfate capsules and Larotrectinib sulfate oral solution were simultaneously declared for listing in China
.

Hengrui, Zhengda Tianqing, Kangfang.
.
.
66 new drugs were approved for clinical use

From October 16th to October 29th, 66 new drugs (involving 100 acceptance numbers) were given implied approval for clinical trials
.
Among them, 49 varieties (80 acceptance numbers) are domestic new drugs, and 17 varieties (20 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 34 chemical drugs, 31 therapeutic biological products, and 1 Chinese patent medicine
.
Among the 49 domestically produced new drugs, 40 are Class 1 new drugs
.

(10.
16-10.
29) Approved clinically domestic/imported new drugs

Hengrui Medicine has 6 new Class 1 drugs approved for clinical use.
HRS9531 injection, SHR-A1921 for injection and HRS-8080 tablets are the first clinical approvals.
Famitinib malate capsules, SHR8554 injection and SHR0410 injection are not the first time.
Approved clinically
.
HRS9531 injection is indicated for type 2 diabetes.
HRS-8080 tablets can inhibit the proliferation of breast cancer cells.
There is no drug with the same target on the market at home and abroad; SHR-A1921 for injection is an antibody drug conjugate targeting tumor-specific antigen There are many similar drugs in the clinical development stage in China
.

AR882 capsule is a class 1 innovative drug developed by Arthrosi.
It is a highly effective and selective uric acid transporter (URAT1) inhibitor, designed to normalize urine urate excretion through URAT1, thereby reducing serum uric acid (sUA) levels
.
Currently, AR882 is in Phase IIb clinical stage in the United States
.
The R&D, production and commercialization of AR882 in China is handled by Poinsettia subsidiary Rui Teng Bio.
Prior to this, Rui Teng Bio participated in Arthrosi's C2 round of preferred stock financing
.

Kangfang Biology has three Class 1 new drugs approved for clinical use, including AK104 injection, AK112 injection and AK119 injection.
The company focuses on the development of innovative new antibody drugs
.
Among them, AK104 is the world's first PD-1/CTLA-4 bispecific antibody; AK112 is the world's first PD-1/VEGF bispecific antibody to enter clinical research; AK119 is a CD73 monoclonal antibody
.
None of the three new drugs has been approved for clinical use for the first time, and the AK104 injection has been submitted for marketing applications for cervical cancer indications
.

Zhengda Tianqing has two new Class 1 drugs approved for clinical use.
TQB2450 injection is PD-L1 monoclonal antibody, which is already in phase III clinical phase; TQB2928 injection is CD47 monoclonal antibody, which is the first clinical approval
.

Kanghong Pharmaceutical's 2.
4 modified new drug KH737 eye drops is intended to be used to delay the progression of myopia in children
.
The active ingredients of the product mainly interact with the relevant receptors of the retina and sclera to inhibit the growth of the eye axis, thereby delaying the progression of myopia
.
Since the beginning of this year, Kanghong Pharmaceutical has obtained 4 clinical approvals, including the 2.
4 new drug KH737 eye drops, the 1 new drug BC3448 for injection, the 2.
2 new drug Conbercept ophthalmic injection and the 3 generic drug Ritaklast Eye drops
.

CSPC, Livzon, Simcere.
.
.
58 new drug clinical applications were accepted

From October 16 to October 29, clinical applications for 58 new drugs (involving 82 acceptance numbers) were accepted by the CDE
.
Among them, 43 varieties (59 acceptance numbers) are domestic new drugs, and 15 varieties (23 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 35 chemical drugs, 22 therapeutic biological products, and 1 Chinese patent medicine
.
Among the 43 domestically produced new drugs, 33 are Class 1 new drugs
.

(10.
16-10.
29) Accepted clinical applications for domestic/imported new drugs

From the perspective of enterprise application status, Hengrui Pharmaceuticals and CSPC are the local companies with the most IND applications; Merck, Novartis, Sanofi, and AstraZeneca are the foreign companies with the most IND applications, each with 2 varieties
.

Hengrui Medicine has declared 3 clinical Class 1 new drugs, including YY-20394 tablets, SHR-1701 injection, and RS2102 for injection; 2 new indication applications, including apatinib mesylate tablets and SHR8058 eye drops Liquid
.

CSPC has declared 3 clinical Class 1 new drugs, including SYHX2001 tablets, recombinant humanized anti-epidermal growth factor receptor monoclonal antibody injection, and recombinant anti-PD-1 fully human monoclonal antibody injection; there are 3 new class 2 drugs.
One, including SYHX2011, Mitoxantrone Hydrochloride Liposome Injection, Docetaxel for Injection (albumin-bound type)
.

Data source: Minet database, CDE, company announcement
.
The data statistics period is from October 16th to October 29th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are omissions, please correct me!