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, in the last week of January 2022 (from January 24, 2022 to January 30, 2022), the drug evaluation center (CDE) of the State Drug Administration received 24 applications for new chemical drugs, preventive biological products and therapeutic biological products submitted by 16 listed companies (including the holding company of listed companies).
One week new drug application
In terms of listed companies this week, Sihuan Pharmaceutical (00460. HK) applied for 3 production applications and Guangdonghectechnologyholdingco.Ltd(600673) Pharmaceutical (01558. HK) applied for 1 production application; Betta Pharmaceuticals Co.Ltd(300558) (300558. SZ), heyu-b (02256. HK), Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) (600521. SH), Sichuan Kelun Pharmaceutical Co.Ltd(002422) (002422. SZ), Cinda Biology (01801. HK) and China biopharmaceutical (01177. HK) apply for 2 clinical applications respectively; Baiji Shenzhou (688235. SH), Fuhong Hanlin (02696. SZ), Guilin Sanjin Pharmaceutical Co.Ltd(002275) (002275. SZ), Huadong Medicine Co.Ltd(000963) (000963. SZ), China Resources Double-Crane Pharmaceutical Co.Ltd(600062) (600062. SH), Connor (02162. HK), Lepu Medical Technology (Beijing) Co.Ltd(300003) (300003. SZ) and China antibody (03681. HK) apply for one clinical application respectively
note: the declarations of different specifications of the same drug of the same company are not listed separately in the above table
One week hot review
\u3000\u3000 1。 North China Pharmaceutical Company.Ltd(600812) recombinant anti rabies virus monoclonal antibody was approved as the "first in China" to fill the market gap
on January 25, North China Pharmaceutical Company.Ltd(600812) (600812. SH) announced that the subsidiary's omutezumab injection had passed the priority review and approval procedure of the State Drug Administration and was approved for listing. This product is a recombinant human anti rabies virus monoclonal antibody injection, which is used in combination with human rabies vaccine to supplement the antibody blank in the process of active immunization of human rabies vaccine. It can directly neutralize rabies virus in the body and play a passive immune role. It is used for passive immunity of patients bitten and scratched by rabies or other rabies virus susceptible animals.
This is the first recombinant anti rabies virus monoclonal antibody approved for marketing in China. according to North China Pharmaceutical Company.Ltd(600812) , the phase II and III clinical trials of the project lasted six and a half years. Up to now, the cumulative R & D investment is about 199 million yuan.
industry insight:
Rabies is an animal borne infectious disease caused by rabies virus infection. The virus mainly invades the human body through damaged skin or mucous membrane. In recent years, the number of reported deaths of rabies has always been in the forefront of legally reported infectious diseases in China. As the incubation period of rabies is generally 1 to 3 months, and the mortality of patients is close to 100%, prevention is particularly important.
Active immunity refers to that the body can actively produce antibodies to obtain immunity, which is mainly obtained through vaccination, and the maintenance time is relatively long; Passive immunity refers to the specific immune ability obtained by the body passively receiving antibodies, sensitized lymphocytes or their products. It is characterized by fast effect, no incubation period, and immunity can be obtained immediately after input, but the maintenance time is short.
Passive immunity is the mechanism of action of omativir McAb injection. At present, there is no recombinant anti rabies virus monoclonal antibody on the market in China, but three companies in China are carrying out similar research, namely Shenzhen Longrui Pharmaceutical Co., Ltd. / Xingmeng Biotechnology (Beijing) Co., Ltd. (phase III), Zhixiang (Shanghai) Pharmaceutical Technology Co., Ltd. / Chongqing Zhixiang Jintai biopharmaceutical Co., Ltd. (phase II), Changchun Bcht Biotechnology Co(688276) (688276. SH) (preclinical research). In terms of R & D progress, Xingmeng biology is the most advanced in mixed preparations.
Other passive immune agents listed in China are anti rabies serum and rabies patient immunoglobulin. According to the North China Pharmaceutical Company.Ltd(600812) announcement, 18 enterprises in China have the approval number of rabies immunoglobulin and have not approved the sales of imported products
source: Yaodu database
In terms of price, according to the data of Yaodu, the bidding price of rabies patient immunoglobulin in 2020 (200iu / bottle) is 140 yuan ~ 180 yuan / bottle. However, according to caixin.com, vaccine expert Tao Lina said that according to body weight, people with 60kg usually need at least 5 doses to complete immunization, which costs more than 1000 yuan. If the price of anti rabies virus monoclonal antibody can be equal to that of rabies patient immunoglobulin, it may have an impact on the existing rabies patient immunoglobulin market.
company comments:
This new drug launch is the first good news after the pre reduction of North China Pharmaceutical Company.Ltd(600812) performance.
On January 14, North China Pharmaceutical Company.Ltd(600812) issued a performance pre reduction announcement. It is estimated that the net profit attributable to the parent company in 2021 will be about 20 million yuan, a year-on-year decrease of 79.45% compared with the net profit of 97.3238 million yuan in 2020. The company attributed the performance reduction to the reduction of non recurring profit and loss events such as government subsidies, with an impact amount of about 80 million yuan.
In the following days, the company's share price began to decline after a slight rise. In about a week, the market value shrank to about 15 billion yuan. Looking back on 2021, North China Pharmaceutical Company.Ltd(600812) also experienced the supply interruption event of centralized mining, and was disqualified from participating in the declaration of national centralized mining from August 11, 2021 to May 10, 2022. The stock price fluctuated like a roller coaster.
The listing of omativumab injection is expected to bring certain performance growth to North China Pharmaceutical Company.Ltd(600812) . According to Southwest Securities Co.Ltd(600369) calculation, if 50% of the blank market penetration is achieved, North China Pharmaceutical Company.Ltd(600812) rabies monoclonal antibody product vaccination is expected to reach 3 million people, and the peak sales will reach 3 billion yuan. According to the net interest rate of 30%, it can contribute 900 million yuan of net profit to the company, which is more than 9 times that of North China Pharmaceutical Company.Ltd(600812) 2020.
The researcher of nuggets innovative medicine noted that as an old API enterprise in China, North China Pharmaceutical Company.Ltd(600812) has been transforming to preparation for 10 years, and its revenue has also begun to grow, but its net profit in the past 10 years has not exceeded the level in 2008. At present, the company's products cover most varieties from raw materials to preparations, involving chemical drugs, biological drugs, health consumer goods, etc. it focuses on the development of biological agents and preparations in new treatment fields such as tumor therapeutic drugs, cardio cerebrovascular drugs and immunomodulatory drugs. The key R & D projects include propofol fumarate tenofovir tablets, recombinant human albumin for injection, etc.
In addition, North China Pharmaceutical Company.Ltd(600812) also cross-border "milk tea" in 2021. The subsidiary Huawei Health launched the zhenyinzi brand and also sold functional health food. As of June 30, 2021, the operating revenue was 85.24 million yuan and the net profit was only 3.35 million yuan.
it is not difficult to see that although the company's determination to transform is firm, its performance effect is limited. The commercialization performance of omativivir monoclonal antibody injection after listing is particularly important for the current North China Pharmaceutical Company.Ltd(600812) .
\u3000\u3000 2。 The third generation insulin of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) has been listed as the second domestic similar competitive products, which have been included in the national centralized purchase
In January 26th, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (600196.SH), a wholly owned subsidiary of sun Jiangsu, Recombinant Human Insulin Lispro Injection, Recombinant Human Insulin Lispro Injection biochemical pharmaceutical Refco Group Ltd (hereinafter referred to as Wan Bang), was approved to be listed. This is China's second domestic Recombinant Human Insulin Lispro Injection, which can be used for diabetes treatment.
industry insight:
Diabetes is a group of metabolic diseases characterized by hyperglycemia. According to the International Diabetes Federation (IDF), global diabetes expenditure in 2021 was about $966 billion, and it is expected to increase to $10276 in 2030. China's diabetes expenditure increased by nearly 10 times between 2011 and 2021, from $17 billion 500 million to $165 billion 300 million in 10 years.
is in the future of diabetes drug market in the background of the trend of diabetes, the aging trend of Chinese population and the increase of Chinese per capita disposable income.
As the only hormone in the body that lowers blood sugar, exogenous insulin can be used to treat diabetes. at present, China's insulin mainly comes from foreign markets. The giants importing insulin include Novo Nordisk, Sanofi and Eli Lilly, accounting for more than 70% of the market share; Domestic insulin is mainly Tonghua Dongbao Pharmaceutical Co.Ltd(600867) (600867. SH), Gan & Lee Pharmaceuticals(603087) (603087. SH) and United Laboratories (03933. HK). in 2020, Tonghua Dongbao Pharmaceutical Co.Ltd(600867) second-generation recombinant human insulin injection market accounted for about 34%, and Gan & Lee Pharmaceuticals(603087) third-generation insulin "changxiulin" accounted for about 40% of China's long-acting insulin market.
Lispro insulin is the third generation insulin. Previously, only Lilly and Gan & Lee Pharmaceuticals(603087) lispro insulin in China were approved for listing. According to the data of Yaodu, in addition to the three enterprises whose products have been listed, Tonghua Dongbao Pharmaceutical Co.Ltd(600867) is also developing insulin Lispro Injection, and phase III clinical trial was just launched in December 2021.
It can not be ignored that the national centralized mining has stirred up the industry pattern. On November 26, 2021, insulin entered the national centralized purchase for the first time. Foreign enterprises represented by Lilly actively responded in this round of centralized purchase, with the largest decline of 73%; Domestic enterprises represented by Gan & Lee Pharmaceuticals(603087) and Tonghua Dongbao Pharmaceutical Co.Ltd(600867) broke into the first few groups with more allocated market volume, and the competition for the market is greater.
But only looking at the three generations of insulin, Lilly and Gan & Lee Pharmaceuticals(603087) were selected in class A and class B respectively. As for the results of national centralized purchase of insulin, some insiders once told the researchers of Nuggets innovative drug that due to the influence of patient compliance and professional team, the domestic substitution process of insulin products may face a buffer period of about two years.
company comments:
The wholly-owned controlling shareholder of Jiangsu Wanbang is Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) once known in the industry as an "investment company in the cloak of pharmaceutical enterprises".
In March 2020, the global covid-19 epidemic spread rapidly, and Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) reached strategic cooperation with biontech on covid-19 vaccine, which is Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) a well-known international project. However, in fact, many drugs under research in Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) were obtained through authorized cooperation, and core subsidiaries were also obtained through acquisition.
For example, Jiangsu Wanbang, which has successfully launched three generations of insulin products this time. According to the annual report of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) 2020, Chongqing Yaoyou, Jiangsu Wanbang and Indian pharmaceutical company Glen Pharma are important holding subsidiaries of the company. Among them, the main products of Jiangsu Wanbang include youlitong (non busitar tablets), Yibao (recombinant human erythropoietin (CHO cells for injection)), Kesheng (Xihuang capsule), wansuping (glimepiride tablets), heparin sodium series, etc. in 2020, the operating revenue was 6.875 billion yuan, the net profit was 774 million yuan, and the contribution to the performance of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) exceeded 20%, ranking second among the subsidiaries, second only to Chongqing Yaoyou.
it is worth noting that the insulin drugs listed by Jiangsu Wanbang this time belong to self-developed innovative drugs, and the company is still developing recombinant insulin glargine. at the end of December 2021, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) announced that Jiangsu Wanbang decided to terminate the clinical trial and subsequent development of the new drug wangliejing tablets. The WAN glimijing tablet is a SGLT-2 inhibitor, which is mainly used for the treatment of type II diabetes. The drug is an authorized cooperation project, and won the Sirona Biochem Corp in January 2014 by Jiangsu Wan bang. to grant authorization.
For the termination of the project, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) said that the decision "is based on the comprehensive evaluation of the subsequent development investment and market value of the new drug, in order to reasonably allocate R & D resources and focus on the advantageous projects in the R & D pipeline".
According to the semi annual report of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) 2021, the company is mainly developing 240 projects such as new drugs, generic drugs, biological analogues and generic drug consistency evaluation
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) main drug projects under research source: company announcement
Researchers of nuggets innovative drugs believe that Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) has a wide layout, involving many fields such as biological drugs, small molecule innovative drugs, cell therapy, mRNA and so on. Drug R & D is moving from integration to self-development. In the future, with the listing of a number of innovative products, revenue growth is expected to accelerate and the product structure will be continuously optimized.
