[Yao Kajun] 26 new drugs have been approved for clinical use, and the popular targets continue to rise. Hengrui, Betta...

July 20, 2021

Yaozhi data shows that in this period (July 9 to July 16), 26 new drugs were approved clinically (32 acceptance numbers); another 41 varieties (52 acceptance numbers) clinical applications were accepted by CDE. More dynamics are as follows:

New Drug Clinical Application·Newly Approved

In this issue, 26 new drugs (32 acceptance numbers) have been implicitly approved for clinical trials, including 12 domestically produced Class 1 new drugs. The clinically approved innovative drugs include PD-1 antibody, CTLA-4 antibody, CD20 monoclonal antibody, HER3 ADC, FAK inhibitor, BCL-2 inhibitor, and indications include childhood myopia, anesthesia, solid tumors, atopic dermatitis, Stroke, herpes simplex virus, etc.

Data source: Yaozhi data

1. SBK001 injection

The drug is the second class 1 new chemical drug independently developed by Chengdu Shibeikang and approved for clinical use. SBK001 injection is a brand-new mechanism of action, a brand-new compound, and has global patents; its indications are: for acute lung injury (ALI), such as the preventive treatment of acute lung injury (ALI), such as surgery, viruses or bacteria.

2.IN10018 tablets

The drug is a FAK inhibitor developed by Boehringer Ingelheim, and Yingshi Bio now has the global development and commercialization rights of the drug. The study found that the combined treatment strategy of FAK inhibitor (IN10018) and KRAS G12C inhibitor can achieve a synergistic anti-cancer effect, and can reduce its drug resistance at the same time to make the anti-cancer effect more durable. IN10018 has been approved by a number of clinical trials in China. It is indicated for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, combined with PD1 for the treatment of advanced or metastatic non-small cell lung cancer, and combined with chemotherapy for the treatment of high-grade serous Ovarian cancer (including fallopian tube cancer and primary peritoneal cancer), locally advanced or metastatic solid tumors and other clinical trials, as well as the approved solid tumors with HRAS mutations this time.

3. Nitrazine for injection

The drug is a Class 1 chemical innovation drug exclusively transferred from Jinan University by Magpie Medicine, and has a unique mechanism of action. Nitrazine efficiently scavenges free radicals, protects mitochondrial function, increases ATP production, promotes autophagy, and restores cell viability. The clinical indication of nitroxazine for injection is approved for the treatment of acute ischemic stroke (combined with endovascular treatment). In addition, nitroxazine tablets for the treatment of ALS are currently undergoing phase II clinical studies in China.

4. SHR-1906 injection

The drug is a new class 1 drug developed by Hengrui Medicine, and its indication is IPF for idiopathic pulmonary fibrosis. According to public information, SHR-1906 is a CTGF antibody, which is also the first domestically produced CTGF antibody. CTGF is a multifunctional heparin-binding glycoprotein, which is usually expressed at low levels, but is significantly enriched in almost all fibrotic conditions.

5. Zebetuzumab injection

The drug is a CD20 monoclonal antibody developed by Zhejiang Borui Bio, a subsidiary of Hisun Pharmaceutical. Zebetuzumab is a differentiated CD20 antibody and a chimeric antibody of the IgG1 subtype. From the amino acid sequence of Zebetuzumab, this product is strictly a biological analogue of rituximab.

6.UB-621 injection

The drug is a fully humanized IgG 1 monoclonal antibody drug developed against herpes simplex virus (HSV). UB-621 can induce high-affinity binding to the gD protein target on the outer envelope of the virus (HSV-1 and HSV-2), preventing the virus from invading the host and inhibiting infection. In August 2020, the product was declared clinically in China for the first time. Indication: Treatment of adult recurrent genital herpes.

7. CAN106 injection

The drug is a long-acting human monoclonal antibody that acts on the C5 target of the complement system and is used to treat paroxysmal nocturnal hemoglobinuria (PNH). Previously, this species was approved by the Singapore Health Sciences Agency (HSA) in IND approval in December 2020 and is currently undergoing a phase I safety test. CAN106, which is being developed by Beihai Kangcheng, can be used to treat a variety of genetic diseases related to complement disorders.

8.ZN-d5 piece

The drug is an oral selective inhibitor of B-cell lymphoma 2 (BCL-2) developed by Zentalis Pharmaceuticals, and the approved indication is non-Hodgkin's lymphoma. BCL-2 is a protein that plays a key role in regulating cell death. Overexpression of BCL-2 has been detected in many cancer types. BCL-2 inhibitors have become an important target for cancer treatment by restoring tumor cell apoptosis.

9. RRx-001 injection

The drug is a next-generation small molecule immunotherapy with good safety, targeting the CD47-SIRPα axis. As a potential immunotherapy that transforms tumors "tolerant to treatment" into tumors that are "sensitive to treatment", RRx-001 can be used as a monotherapy or in combination with chemotherapy, other immunotherapies, radiotherapy and targeted drugs . Saisheng Pharmaceutical was authorized to introduce from the US EpicentRx, and obtained 10-year patent commercialization licenses in Mainland China, Hong Kong, Macau, and Taiwan. The approved indication is extensive-stage small cell lung cancer.

10. Atropine Sulfate Eye Drops

The drug is a low-concentration atropine 0.01% eye drops developed by Ou Kang Weishi. Recently, OT-101 was approved by the State Food and Drug Administration to carry out a phase III clinical trial for the treatment of myopia in children. Low-concentration atropine solutions are unstable and have long been a technical obstacle to commercialization. The storage and drug delivery system developed by Okvision can solve this problem. Previously, the Phase III clinical study of OT-101 has been approved by the US FDA. In May 2021, the OT-101 international multi-center phase III clinical trial was accepted in the UK.

11.U3-1402

The new HER3 targeting antibody conjugate (ADC) drug developed by Daiichi Sankyo is intended for non-small cell lung cancer (NSCLC). Patritumab, the antibody part of the drug, is a HER3-targeting monoclonal antibody jointly developed by U3 pharma and Amgen. In 2008, Daiichi Sankyo acquired U3 pharma and obtained its research patritumab and related intellectual property rights; in 2016, due to clinical With poor data, Daiichi Sankyo terminated the development of Patritumab for the treatment of NSCLC, but the advent of ADC technology gave this monoclonal antibody a new lease of life. Daiichi Sankyo developed it as an ADC drug and obtained U3-1402. U3-1402 has progressed to phase II clinical practice abroad.

12. Batilimumab injection / zefliximab injection

Batilizumab and Zefliximab are the projects introduced by Betta Pharmaceuticals from Agenus. Betta Pharmaceuticals has the sole use or combination of other drugs in China (including Hong Kong, Macau and Taiwan) in addition to intravesical administration. The exclusive right to develop and commercialize batilimumab and zefliximab in all indications of. The two drug clinical trials of the combination of batilimumab injection and zefliximab injection for the treatment of advanced solid tumors have been approved by the National Medical Products Administration and are intended to be used for the treatment of advanced solid tumors. Battilimumab is a tumor immune monoclonal antibody developed by Agenus. It is a recombinant monoclonal antibody that binds to programmed death receptor 1 (PD-1). It has the ability to inhibit PD-1 and its ligand (PD-L1). , PD-L2) The ability to combine. Zefliximab is a human anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) monoclonal antibody (Mab), which can inhibit the inhibitory effect of CTLA-4 on tumor-specific T cell immune responses.

New Drug Clinical Application·New Acceptance

In this issue, CDE has newly accepted clinical applications for 41 new drugs (52 acceptance numbers). Among them, 35 varieties (43 acceptance numbers) are domestic new drugs, and 6 varieties (9 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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