[Yao Kajun] 37 new drugs were approved for clinical use, from CP Tianqing, Hengrui, Kelun...

June 28, 2021

Highlights:

1. 37 new drugs obtained implied approval for clinical trials, including 24 domestically produced Class 1 new drugs
2. CDE newly accepted clinical trial applications for 19 new drugs (33 acceptance numbers)
3. Four new class 1 anti-tumor drugs of Zhengda Tianqing were approved for clinical use
4. Many new drugs of Hengrui have been approved for clinical use, including two new anti-tumor drugs and one eye drops

Yaozhi data shows that in this period (June 18 to June 25), 37 new drugs have been approved clinically (59 acceptance numbers); another 19 varieties (33 acceptance numbers) clinical applications have been accepted by CDE. More dynamics are as follows:

New Drug Clinical Application·Newly Approved

In this issue, 37 new drugs (59 acceptance numbers) have been implicitly approved for clinical trials, including 24 domestically produced Class 1 new drugs. Approved clinical innovative drugs include hematological tumors, solid tumors, diabetes, analgesia, myopia and other indications.

Data source: Yaozhi data

1. Four new drugs of Chia Tai Tianqing have been approved for clinical use!

TQB3820 tablets, TQB3823 tablets, TQB3824 tablets and TQB3909 tablets are new class 1 anti-tumor drugs, covering indications for hematological tumors and solid tumors; among them, TQB3823 tablets are new PARP1/2 target drugs.

2. Many new drugs of Hengrui have been clinically approved

SHR7280 tablet is an oral small molecule GnRH receptor antagonist, which can block the binding of endogenous GnRH and GnRH receptor, inhibit the synthesis and release of luteinizing hormone and follicle stimulating hormone and other gonadotropins, and reduce testosterone and estradiol Levels of sex hormones such as alcohol. The clinical indication approved this time is prostate cancer. SHR-1701 injection is a programmed death ligand 1 (PD-L1)/transforming growth factor-βII receptor (TGF-βRII) antibody. SHR-1701 has initiated a number of clinical studies. The approved indications are gastric cancer or gastroesophageal junction cancer and renal cell carcinoma. HR19034 eye drops is a 2.4 category new drug declared by Chengdu Shengdi Medicine, which is intended to be used for the treatment of myopia.

3.ICP-033

The drug is a novel multi-target receptor tyrosine kinase (RTK) inhibitor independently developed by Nuocheng Jianhua, which can selectively inhibit discoid domain receptor 1/2 (DDR1/2), vascular endothelial growth factor receptor Body 2/3 (VEGFR 2/3) and platelet-derived growth factor receptor (PDGFR α/β) and other receptor tyrosine kinases. It is planned to be used alone or/in combination with immunotherapy and other targeted drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors. This is also the sixth innovative drug of Nuocheng Jianhua that has entered the clinical stage.

4. KL280006 injection

The drug is a peripheral kappa opioid receptor (KOR) agonist developed by Sichuan Kelunbotai, a subsidiary of Kelun Pharmaceutical, and is intended for the treatment of uremia and itching. Uremia pruritus is the second indication for KL280006 injection to obtain clinical research approval. The first indication "acute pain" was approved by the National Medical Products Administration in July 2018.

5.WXSHC071 capsules

The drug is a three-target inhibitor of Toho Purple Star (THDBH101 capsules/WXSHC071 capsules). It is a class I innovative new drug. The clinical trial indication for this application is type II diabetes. Under the synergy of multiple target mechanisms, the product is expected to further strengthen the hypoglycemic effect, and at the same time achieve the protective effect of cardiovascular, kidney, liver, etc., play the role of multiple mechanisms to play a superimposed effect, and establish in addition to hypoglycemic effect The basis of clinical benefit.

6.ASKC852 tablets

The drug is a Class 1 innovative drug jointly developed by Jiangsu Aosaikang Pharmaceutical Co., Ltd. and Shanghai WuXi AppTec with independent intellectual property rights. ASKC852 tablet is a small molecule immunomodulatory drug. Preclinical studies have found that ASKC852 alone can exhibit anti-tumor effect, and its combination with PD-1/L1 antibody shows a significant synergistic anti-tumor effect. In addition, it can effectively inhibit cancer cells. Transfer.

7.SR419 capsule

The drug is a candidate drug for the treatment of peripheral neuropathic pain with a new mechanism independently developed by Thermo Biologics. SR419 can inhibit chronic pain caused by nerve damage. At the same time, this type of drug specifically acts on the site of pain without passing through the blood-brain barrier, reducing many potential central nervous system side effects. It can be used to treat neuropathic pain and cancer pain, thereby replacing Opioids. Preclinical data shows that SR419 has the potential advantages of strong potency and no central side effects, and is expected to become the world's first analgesic for a specific target.

8.XNW1011 capsule

The drug is a BTK inhibitor of Xinglian Pharmaceutical, and the approved indication is pemphigus vulgaris (PV).

9.ES102 injection

The drug is a hexavalent antibody that targets and activates OX40 developed by Kewan and has a "First-in-class" design concept. Compared with the traditional bivalent or quadrivalent OX40 antibody, ES102 has stronger immune activation ability, and has been shown in preclinical single drug and combined immune checkpoint inhibitor PD-1/PD-L1 anti-tumor drug effect. The approved indication is advanced malignant solid tumor.

10. FDA018 antibody coupling agent for injection

The drug is an anti-tumor ADC drug targeting Trop-2, and the clinical indication to be developed is solid tumors. Trop-2 (human trophoblast cell surface glycoprotein antigen) has different levels of expression in normal human tissues, but its expression level will increase significantly in many tumors, such as breast cancer, lung cancer, and gastric cancer.

11.UB-421 injection

The drug is a humanized, Fc deglycosylated IgG1 monomer that targets the CD4 receptor domain 1 (domain 1) of the T cell surface molecule, which is the site where HIV recognizes and binds to infect host cells. In this approved trial, UB-421 is combined with Chidamide, a small molecule drug, to evaluate the efficacy of the treatment plan in reducing the HIV virus reservoir (functional cure) in HIV patients whose viral load is stably suppressed.

New Drug Clinical Application·New Acceptance

In this issue, CDE has newly accepted clinical applications for 19 new drugs (33 acceptance numbers). Among them, 14 varieties (21 acceptance numbers) are domestic new drugs, and 5 varieties (12 acceptance numbers) are imported new drugs. More developments are as follows:

Data source: Internet public data such as Yaozhi data, corporate announcements, etc.

Information source: public information on the Internet such as Yaozhi.com, corporate announcements, etc.

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