Can I lose a shot?Ten billion weight loss pills will welcome the "new net red", Oli Si, unique status and unique status

Author:21st Century Economic report Time:2022.07.18

21st Century Business Herald reporter Zhu Ping intern Li Jiaying Beijing reported that recently, East China Pharmaceutical Licula Peptide injection application for listing permit for obesity or overweight indications was accepted. Essence This is the first domestic Lichelt peptide to apply for weight loss indications. It is suitable for adult patients who need long -term weight management. They are auxiliary treatment for low -calorie diet and increased exercise. Adults who take medicine are generally obese people, and the initial weight index (BMI) is not less than 30kg/m2. Alternatively, the patient's weight is overweight, and the BMI is not less than 27kg/m2 and is accompanied by at least one type of weight -related complications, such as hypertension, type 2 diabetes, or abnormal blood lipids.

Leralu peptides are GLP-1 drugs and can be used for diabetes indications, obesity or overweight indications. From the perspective of clinical manifestations, such drugs have significant treatment effects on the blood glucose control of type 2 diabetes in adults; at the same time, Leraru peptides have the effects of weight loss, sugar reduction, and cardiovascular benefits. They are also approved abroad abroad. The treatment of patients with obesity or overweight is considered to be a target of relatively mature, stable and safety in the field of obesity or overweight.

However, the obesity or overweight adaptation of the original deserted Leralu peptide injection has not been approved in the country. The Nordor Nord's original pharmaceutical product Liculugin was approved for treatment of type 2 diabetes. Indications, companies that currently lay out Leralu -peptide weight loss pens are only East China Pharmaceutical/Jiuyuan Gene, Jiangsu Wanbang, Ameike/Nobot, which also provides a broad space for domestic imitation products.

Caitong Securities pointed out that compared with the United States, there are fewer domestic compliance with weight loss drugs. At present, there is only Oli Sisi, but Olis can only inhibit the absorption of fat and cannot inhibit the absorption of carbohydrates. Low -carbon water diet and weight control effect is limited. Therefore, domestic obese people urgently need a safe and effective compliance weight loss drug. As of 2019, the size of overweight and obese population over 18 years of age has reached 192 million. The huge audience group also brings a broad market space. It is expected that the compliance market for weight loss pills in 2025 is expected to exceed 12 billion yuan. According to the research report of Xingye Securities, according to Novo Nord's 2021 annual report, the sales of the two products of Licoluta peptide and Smegugu peptide in China were 1.792 billion yuan, accounting for the overall GLP-1 market sales 74%, it is estimated that the domestic GLP-1 market reached 2.421 billion yuan in 2021. If East China Medicine is successfully approved to be listed on the listing of Licoluta, based on its sales capacity in the endocrine department, it is expected to achieve a peak of sales of 1.345 billion yuan in weight loss indications.

It is expected to impact 1 billion weight loss drugs

On the evening of July 13, East China Pharmaceutical issued an announcement that the company's Licolaptopptide injection was accepted for a listing permit for obesity or overweight indications, and the specification/acceptance number was 3ml: 18mg (pre -filled injection pen). This product is suitable for adult patients who need long -term weight management. As auxiliary treatment of low -calorie diet and increased exercise: the initial weight index (BMI) of adult patients is: ≥30kg/m2 (obesity), or ≥27kg/m2 (overweight) And with at least one type of weight -related complication (such as hypertension, type 2 diabetes, or abnormal blood lipids).

The announcement shows that there is no domestic manufacturer to submit a listing application for obesity or overweight adaptiveness in China. East China Pharmaceutical is the first in China to submit two indications for Licula peptide biomedicine (diabetes indication, obesity or overweight or overweight Indications) Application and is expected to become the first enterprise to be approved.

It is understood that on June 23, East China Pharmaceutical announced a strategic cooperation with the Middle East company Julphar. Julphar will get the two indications: Diabetes and Loss of Diabetes and Loss of the Company Leraru Peptide injection product in the UAE, Saudi Arabia, Egypt, Kuwait, Oman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Alman, Aman The development, production and commercialization of 17 countries such as Barin and North Africa.

Caitong Securities pointed out that traditional hypoglycemic drugs have a large number of adverse reactions and fierce manufacturer competition, which has been included in the national drug collection, the market size has shrunk sharply, and gradually enters the recession period; It will face the same dilemma, and compound preparations have become a new trend of DPP-4 inhibitors. The two new drugs, SGLT-2 inhibitors and GLP-1 receptor agonists, have favorable promotion of multiple factors such as multiple benefits, incorporated into the medical insurance directory, the expiration of the original research drug patent, and the rapid development of generic drug technology. The market size will continue to expand , Align with the international market.

It is understood that, in addition to Akaba candy, East China Medicine has formed an innovative drug and differentiated generic drug product pipeline in the mainstream treatment target of diabetes clinical treatment targets, and more than 20 commercialization and research products are developed. Previously, China and the United States submitted a listing permit for the listing of diabetes indications to the NMPA in August 2021, and received acceptance in September of the same year. This indication has been checked by drug registration and is expected to be approved by the end of 2022. On December 3rd, the company's oral blood glucose reduction drugs were first included in the "National Medical Insurance Catalog (2021)" for the first time.

In addition, East China Pharmaceutical is constructing a product pipeline that combines global innovative drugs and biochemical analogs around the GLP-1 target. There are 5 innovative products and biochemical products that have been under research.

Caitong Securities believes that East China Pharmaceuticals also have Olisa capsules on sale, and it is expected to form a rich product echelon with oral and injection with the company's subsequent Licolaptide peptide weight loss indications. It is worth noting that in diabetic indications, East China Pharmaceutical Leraru peptide injection is also the first domestic drug to be submitted to the listing application, and the drug registration verification has been completed. It is expected to be approved to be listed in China by the end of 2022. Only Nuo and Nord's original drug research products in the domestic market are sold for treatment of type 2 diabetes. The weight loss indications have not been approved.

Xingye Securities believes that the Lichel peptides developed by East China Pharmaceuticals are in the first echelon among domestic manufacturers. Type 2 diabetic indications have been declared NDA. It is expected that registered approval can be obtained within this year. After being approved by the items, it is expected to quickly increase the performance of the company's pharmaceutical sector with the sales advantage accumulated in the diabetes field in the field of diabetes.

Xingye Securities assumes that when reaching the peak value, East China Pharmaceutical Leraro peptide is priced at 5,500 yuan for the annual treatment cost, and two thousandths of obesity patients are treated with Lillaoton peptides for treatment. Obesity. In view of the prominent sales capabilities of Huadong Medicine in the past and its expected to be the first to obtain obesity indications in domestic manufacturers. The sales peak of China is 1.345 billion yuan.

The weight loss market has four smoke

In fact, with the rapid economic development and the improvement of people's living standards, the number of obesity patients in my country has increased significantly. According to the "Nutrition and Chronic Diseases of Chinese Residents (2020)", more than 50%of adult residents are overweight or obese, 6- The overweight/obesity rates under the age of 17 and under 6 years of age reached 19%and 10.4%, respectively.

According to the "Principles of the Clinical Test Technical Guidance of Drug Control Drugs" released by CDE, there is currently only one drug in my country that is approved for treatment of patients with obesity or overweight patients in China. Great unsatisfactory clinical needs.

Olis is a gastrointestinal lipase inhibitor. By forming a covalent bonding binding with the active liponine in the gastrointestinal cavity and pancreatic lipase, the lipase can not live the fat in the food (mainly the glycerin Triglysis is decomposed into absorbable free fatty acids and monoclonal glycerin, thereby reducing calorie intake, controlling weight gain, and achieving the purpose of controlling weight, hypoglycemic, and lowering blood pressure.

According to Mine.com data, as of now, Olis has more than 20 Chinese medicines with different dosage forms and different specifications. Production enterprises include Zhi En Pharmaceuticals, Roche Pharmaceuticals, Haizheng Pharmaceuticals, East China, East China, East China, China, Huahua, Hua, China Mori medicine and so on.

Other weight loss drugs are the previous one of the Lichel peptides. Because the GLP-1 drug represented by Lilanton peptides presents a significant treatment effect in weight loss, it has the effects of weight loss, sugar reduction and cardiovascular benefit. The target has increased rapidly in recent years.

The former Research Francono and Nord of Liculugin, in 2009, 2010 and 2011, their diabetic indications received the European Drug Administration (EMA), the US Food and Drug Administration (FDA), and the former national food and drug supervision and management The bureau approves the listing (now the State Drug Administration, NMPA). In 2014 and 2015, their obesity or overweight indications were approved by FDA and EMA respectively. However, at present, this adaptive disease has not been approved in China.

Information of INSIGHT database shows that at present, 17 companies in China (including the original research) have developed Licula -peptides. Except for China and the United States, only 3 companies in China are currently undergoing obese or overweight adaptation Clinical trials of the symptoms. As of now, the obesity or overweight adaptation of the original deserted -Lara -peptide injection has not been approved in China. East China Pharmaceutical's Licolu peptide injection applied for acceptance is a biological similar medicine for the original drug. This move broke the previous situation, and the market for hypoglycemic and weight loss has ushered in new changes.

In fact, it is not only Leralugu, but another recent endocrine therapy R & D has also gained new progress. On June 29 this year, East China Pharmaceutical announced that the clinical trial application of Simeoguptide injection was approved by the State Drug Administration. Smeglugin injection is also a GLP-1 drug, which reduces blood sugar by stimulating insulin secretion and reducing the secretion of cordyl glucose. In addition, the mechanism to reduce the blood sugar in Smeglugan also involves early stomach emptying after a slight delay, which can reduce appetite and reduce food intake, and induce weight loss.

在减重领域,已然烽烟四起,据Insight数据显示,在奥利司他、利拉鲁肽、司美格鲁肽这三种药物上,目前包括上述提到的海正药业、华东医药、 More than 40 companies including Shanghai Renhui Biological, Meimei, Lizhu Group, East China Pharmaceutical, etc. are layout. Who will get the top spot and become a big winner still wait and see.

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