Nuggets innovative medicine is jointly launched by the daily economic news and Yaodu data. It aims to interpret the progress and trend of new drug research and development, analyze product competitiveness and market prospects, gain insight into the context of pharmaceutical capital, and witness the high-quality development of the pharmaceutical industry.
According to the data of Yaodu, from February 21, 2022 to March 6, 2022, the drug evaluation center (CDE) of the State Drug Administration received 19 applications for new chemical drugs and therapeutic biological products submitted by 13 listed companies (including the holding company of listed companies).
New drug application hot list
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New drug hot review
\u3000\u3000 1. Jiangsu Sihuan Bioengineering Co.Ltd(000518) new type of diabetes oral medicine to declare the listing of Heng Rui similar drugs first approved
On February 28, CDE’s official website showed that the application for listing of class 1 new drug jiaglijing tablets of Sihuan medicine was accepted.
According to the disclosure information of Sihuan medicine, jiaglijing is an inhibitor of sodium glucose cotransporter 2 (sglt-2). By inhibiting sglt-2, it reduces the reabsorption of glucose by renal tubules, so as to increase urinary glucose excretion and reduce blood glucose level.
internationally, SGLT-2 inhibitors are new oral hypoglycemic drugs used in the treatment of type 2 diabetes. Garg Leo Jing of the four ring medicine is the 1 China’s 1 innovative drug SGLT-2 inhibitor.
industry insight:
It is understood that for type 2 diabetes, according to the different stages of the onset and treatment of patients, the demand for drugs is also different. Currently, the global diabetes treatment drugs can be broadly classified into insulin, GLP-1, diguanidine, glucosidase inhibitors, sulfonylurea, thiazolidineated two ketones, glennaide, DPP-IV inhibitors and SGLT-2 inhibitors.
In the field of oral hypoglycemic drugs, sglt-2 inhibitors are the mainstream drugs at present, there are five sglt-2 inhibitors listed in China, including etoglitazone tablets of MSD, kaglitazone tablets of Johnson & Johnson, Enlai tablets of Eli Lilly, dagglitazone tablets of AstraZeneca and hengglitazone tablets approved by Jiangsu Hengrui Medicine Co.Ltd(600276) at the end of 202 7 among them, dapagliflozin, englitazin and kaglitazin have all been included in the medical insurance catalogue of version 2021, and generic drugs are listed in China.
As the first sglt-2 inhibitor, AstraZeneca’s sales of dagliejing tablets have reached the threshold of 1 billion yuan. Relevant data show that in the first half of 2021, the terminal sales of dagliejing in public medical institutions in China alone exceeded 900 million yuan, a year-on-year increase of 312.19%.
Among Chinese pharmaceutical enterprises, except for Jiangsu Hengrui Medicine Co.Ltd(600276) and Sihuan pharmaceutical, which took the lead in crossing the line, Guangdonghectechnologyholdingco.Ltd(600673) jungliejing, Tianjin Pharmaceutical Research Institute’s tagliejing, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) wangliejing and Shanghai Shanghai Allist Pharmaceuticals Co.Ltd(688578) aigliejing have entered the clinical stage, and Guangdonghectechnologyholdingco.Ltd(600673) jungliejing has entered the clinical stage III.
company comments:
Sihuan pharmaceutical started with generic drugs, and then its business gradually involved medical beauty, innovative drugs and other fields. In 2020, the company determined the dual main business strategy of medical beauty + biopharmaceutical.
In the capital market and pharmaceutical industry, Sihuan pharmaceutical has attracted more attention from the outside world, especially its medical beauty business. Acting botulinum toxin brand letibao and other medical beauty businesses constitute the main increment in the performance of Sihuan medicine, and its contribution rate is also gradually increasing. In the first half of the year, the operating income of the medical ring business was 1.35 billion yuan, accounting for 1.95% of that in the first half of 2021; The net profit attributable to the parent company was 610 million yuan, with a year-on-year increase of nearly 308%, of which letibao, which was approved to be listed in China in February last year, made a great contribution.
but at present, the main source of revenue of Sihuan pharmaceutical is generic drugs in non key monitoring directories. In the first half of last year, this part of business revenue accounted for 62.5% of the company’s total revenue. In the field of innovative drugs, the company has not yet formed revenue
The company’s innovative drug research and development platform is mainly divided into Xuan bamboo biology and Hui Sheng biology, the former layout of tumors, metabolic diseases, infections and other fields, the latter mainly layout diabetes and other complications of the whole line products.
Take the diabetes pipeline of Hui Sheng biology as an example, it now has about 15 product pipelines, covering two to four generation of insulin and quick acting products. Among them, in addition to garglitazone whose listing application has been accepted, the fourth generation degu insulin is undergoing phase III clinical treatment, and the biological similar drug insulin aspart has completed phase III clinical treatment and is preparing for NDA application. In addition, Huisheng biology has also arranged GLP-1 analogues represented by liraglutide and somaluptide.
“Nuggets innovative drugs” researchers believe that China’s sglt-2 inhibitor drugs have been occupied by imported products for a long time, and China’s generic drug layout is also very active. Under the background that many original drugs in China have entered the medical insurance catalogue and generic drugs are active, gagglitazone is bound to face fierce competition after listing but SGLT-2 inhibitor drugs can complement each other with other hypoglycemic agents, and its single drug / combination therapy can be used to treat patients with type 2 diabetes and heart and kidney risk factors, and there is an additional incremental market. with the advancement of new drug development, its application prospect is expected to be further improved.
Sihuan pharmaceutical told the researchers that as of the middle of last year, the company had more than 1000 professional marketing teams, more than 3000 distributors and more than 20000 sales managers, of which nearly 40% were responsible for selling Sihuan products. The group’s sales network covers nearly 15000 hospitals, covering up to 100% of the provinces. company has a complete sales team and system to support the commercialization of gagreggin tablets after listing .
\u3000\u3000 2. China’s first ror1 ADC cornerstone pharmaceutical cs5001 clinical trial application accepted
On March 3, CDE’s official website showed that the clinical trial application of cornerstone pharmaceutical cs5001 for injection was accepted. This is a potential global best antibody coupled drug (ADC) targeting tyrosine kinase like orphan receptor 1 (ror1). It is also the first ror1 ADC drug in China. It was approved by FDA in January this year.
industry insight:
Cs5001 was originally developed by legochem Biosciences (LCB). In October 2020, cornerstone pharmaceutical introduced the global (except South Korea) development and commercialization interests of cs5001, with a total transaction amount of US $363 million (US $10 million advance payment + US $353 million mileage fee).
ROR1 is a typical tumor embryo protein, which is low expressed or not expressed in adult tissues, and is highly expressed in various tumors (various types of leukemia, non Hodgkin lymphoma, breast cancer, lung cancer and ovarian cancer). Cs5001 is an ADC targeting ror1, which has many differentiated characteristics, including proprietary site-specific coupling, tumor selective cleavable linker and prodrug technology.
At present, there are 11 ADC drugs approved by FDA. There are four ADC drugs on the market in China, including ogaitozumab, enmetrastuzumab, vibtuximab and vidicizumab of Rongchang biology.
as for ror1 target, Baili pharmaceutical has applied for PD-L1 / 4-1BB / CD3 / ror1 four antibodies, which is the first ror1 targeted new drug in China; Zilovertamab vedotin of MSD was also approved for clinical use in China on January 13 this year
company comments:
Cornerstone pharmaceutical mainly focuses on the field of tumor immunity and precision therapy. Four drugs have been approved for listing in China, including avatinib, pratinib, shuglimab and avonib. Among them, avatinib and pratinib were introduced from blueprint, and avonib was introduced from Agios.
At the beginning of this year, cs5001 was approved by FDA to carry out clinical research, which is regarded as another milestone in the cornerstone pharmaceutical pipeline 2.0 strategy.
In the public statement of cornerstone pharmaceutical, its 2.0 pipeline will focus on two emerging treatment modes – ADC and multispecific antibody. In addition to the above cs5001, cs2006 of cornerstone pharmaceutical is a three specific antibody targeting PD-L1 / 4-1BB / has introduced from numab therapeutics. In September 2021, the application for clinical trial of the drug in China was approved.
In addition, cornerstone pharmaceutical has also reached cooperation with dote biology on the next generation antibody technology platform. The two sides will cooperate to develop a number of antibody drugs that are the first or the best of their kind.
In the public information disclosure, cornerstone pharmaceutical said that it is expected to submit one to two ind applications in 2022 to further promote the progress of drug research. Judging from the clinical application progress of cs5001 and cs2006, the aforementioned planning of cornerstone drugs is proceeding at the expected pace.
“Nuggets innovative drugs” researchers believe that under the background of China’s new drugs repeatedly emphasizing “filling the unmet clinical needs”, the development of FIC, BIC and differentiated new drugs has become the common choice of powerful new drug R & D enterprises. As four products have been listed and constitute the cornerstone of commercial income, the construction of R & D pipeline 2.0 is an inevitable choice for the pharmaceutical industry
but it is worth noting that three of the four products approved by cornerstone pharmaceutical are imported products from BD, and the aforementioned cs5001 and cs2006 are also imported products this phenomenon tests the “vision” of enterprises. At the same time, the continuous breakthrough of transaction amount also shows that the cost of importing from overseas is becoming higher and higher. Cornerstone pharmaceutical also needs to fill in the blank of listing more products with independent intellectual property rights.
