The diabetes field welcomes new drugs again, PD-1/PD-L1 competition is fierce, and a large number of generic drugs are coming!

What to watch this week

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In this issue (October 22 to October 29), the diabetes field welcomes two new drugs, PD-1/PD-L1 competition is fierce, and a large number of generic drugs are coming.

Domestic Review and Approval·New Trends

This week, CDE has 141 acceptance numbers (90 varieties) reported for production and processing status updates, including Shanghai Yizhong Paclitaxel Polymer Micelles for Injection, Yichang Dongyang Sunshine Insulin Glargine Injection, and Novo Nordisk Glucomat Lira Lutide injection has attracted much attention, and more developments are as follows:

Data source: Yaozhi data

Shanghai Yizhong's new class 2 drug "Paclitaxel polymer micelles for injection" has been approved for listing!

Shanghai Yizhong’s core product paclitaxel polymer micelles for injection ("paclitaxel micelles") was approved for marketing.

Paclitaxel is a cornerstone drug for the treatment of tumor diseases and chemotherapy, and it has a wide range of clinical applications

Another insulin glargine was approved for listing

Yaozhi data shows that Yichang Dongyangguang's insulin glargine has been approved for listing

Insulin glargine is one of the types of centralized insulin procurement.

Data source: Yaozhi data

With the arrival of more insulin products on the market and the arrival of centralized procurement, the insulin market is facing a further reshuffle, the localization replacement rate will further increase, and the domestic insulin competition landscape will become more diversified

Novo Nordisk's new diabetes drug "Insulin degludec and liraglutide injection" approved in China

Recently, Novo Nordisk Nuovo ® (De Glutin and Liraglutide Injection) was approved to be marketed in China.

It is reported that Novo Benefit® is the world's first basal insulin glucagon-like peptide-1 receptor agonist (GLP-1RA) injection, which is composed of insulin deglubber and liraglutide, a breakthrough fusion of insulin deglu Compared with the two-component advantage of liraglutide, the two main components work through complementary mechanisms to effectively control blood sugar throughout the day once a day

Domestic review and approval, new acceptance

This week, CDE added 44 production acceptance numbers, totaling 32 varieties, including Li's First Pharmaceutical Factory's first injection of Lizumab injection, Lepu BioPutlizumab injection, and Maibo Pharmaceuticals CMAB007 for injection.

Data source: Yaozhi data

The fifth domestic paragraph! The PD-L1 of Li's Pharmaceutical Factory declares and goes on the market

Recently, the new drug listing application of the anti-PD-L1 monoclonal antibody Socazolimab injection (Socazolimab) submitted by Zhaoke Tumor Drug, a subsidiary of Li's Pharmaceutical Factory, has been accepted by the State Food and Drug Administration

Socazolimab is a fully human anti-PD-L1 monoclonal antibody against tumor PD-L1 protein, which can release the immune system caused by tumor cells

According to Yaozhi data, this is the fifth domestic PD-L1 to be declared for marketing, and it is also the first domestic PD-1/PD-L1 to be declared for second-line cervical cancer

Data source: Yaozhi data

In addition to the ones that have been declared for the market, there are also a number of domestically produced PD-L1s in the clinical research stage
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Among them, Hengrui SHR-1316 (Adbelizumab Injection) has completed phase III clinical research and is expected to apply for listing in the near future
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In addition, Pfizer Aviluzumab, Chia Tai Tianqing TQB2450, and Hengzhixiang Pharmaceutical GR1405 are all in the phase III clinical stage
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Lepu Biologics PD-1 Putlimumab declares the second indication

Recently, Lepu Bio's PD-1 monoclonal antibody pucotenlimab injection (pucotenlimab, HX008) for the second indication for marketing was accepted, and "medicine eligible for approval with conditions" was included in the public announcement of the proposed priority review category It is suitable for the treatment of patients with advanced solid tumors of highly microsatellite instability (MSI-H) or defective mismatch repair (dMMR) who have previously received first-line and above systemic treatment failures
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Public information shows that Pratellizumab is a humanized monoclonal antibody targeting human PD-1 through the use of human IgG4 subtype
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The drug for the treatment of melanoma has been submitted for marketing application in July this year and is still under review
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In addition, the clinical research of Putrizumab in the treatment of gastric cancer and gastroesophageal junction cancer, non-small cell lung cancer, triple-negative breast cancer and other indications is underway.
Among them, the second-line treatment of gastric cancer has carried out a registered phase III clinical study
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At present, only 3 anti-PD-1 monoclonal antibodies at home and abroad have been approved for the treatment of MSI-H/dMMR tumors, and domestic PD-1/PD-L1 has not yet been approved for this indication
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Maibo Pharmaceutical's ``omalizumab'' biosimilar drug submitted for marketing

Maibo Pharmaceutical's CMAB007 (Omalizumab biosimilar) application was accepted by CDE for the treatment of allergic asthma
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Omalizumab is a recombinant humanized anti-immunoglobulin E (IgE) monoclonal antibody, used for the treatment of medium/high doses of inhaled corticosteroids plus long-acting β-adrenergic receptor agonists and still not available New monoclonal antibody drug for fully controlled asthma patients
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Clinical trial results show that CMAB007 can improve the condition of asthma patients and reduce the incidence of acute asthma with lower doses of inhaled corticosteroids
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It is reported that CMAB007 is China's first domestic allergic asthma therapeutic antibody new drug to be submitted for NDA, and it is also the second drug submitted by Maibo Pharmaceutical to apply for marketing
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According to a press release from Maibo Pharmaceuticals, CMAB007 is expected to expand its indications to chronic idiopathic urticaria, seasonal allergic rhinitis and food allergies in the future
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Novartis CDK4/6 inhibitor "Libexili succinate tablets" listed in the domestic newspaper

Yaozhi data shows that Novartis’ CDK4/6 inhibitor "ribexili succinate tablets" has been accepted by the State Food and Drug Administration
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Ribociclib is a selective cyclin-dependent kinase inhibitor that helps slow the progression of cancer by inhibiting two proteins, cyclin-dependent kinase 4 and kinase 6 (CDK4/6)
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The drug was approved for marketing in the United States as early as March 2017 under the trade name Kisqali.
It has been approved for a variety of breast cancer treatments
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