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In order to solve the unmet clinical needs, Health Yuan, Hengrui Pharmaceutical, and China Biopharmaceutical have launched fierce battles in the field of respiratory medicine
.
In addition, in the primary market, there are also many investment institutions betting on young pharmaceutical companies
.
For example, Nuance, which focuses on high-quality specialty drugs in the respiratory field, as well as anemia and analgesia
Pharma), which has completed four rounds of financing totaling more than US$200 million, and the investors involve diversified investors such as Matrix Partners Venture Capital, Cambridge Capital, and Kangchen Pharmaceutical, and its strength should not be
underestimated.
▲Source of Yourui Pharmaceutical's financing process: Tianyancha
The four rounds of financing totaled more than $200 million, 5 commercial products, and 5 drug candidates
The four rounds of financing totaled more than $200 million, 5 commercial products, and 5 drug candidatesFounded in 2014 and located in Shanghai, the "magic capital", Yourui Pharma focuses on the research and development of innovative drugs for respiratory diseases, and has a mature commercial product matrix
in the fields of iron deficiency anemia and emergency care treatment.
From the perspective of management, the leadership team of Unipharma has diverse backgrounds, ranging from venture capital to core members
from leading companies in the industry, such as AstraZeneca (AZ), WuXi AppTec, McKinsey, and BMS.
For example, Shao Yibo, founder & chairman of the company, is Matrix, a top venture capital firm in the United States
Co-founder of Partners, Jingwei China, Shanghai Nova Pharmaceutical, eBay and BabyTree; Co-founder & CEO Mark G
Lotter was one of AstraZeneca's first executives in China, where he built and developed AZ's sales business and founded the venture-backed pharmaceutical company Nova Mai (which was merged into SCLN, a U.
S.
-listed company in 2011).
You know, AstraZeneca is one of the global giants in the respiratory field, and it is it that introduces respiratory therapy such as inhaled corticosteroids, bronchodilators, and atomization therapy into China
.
▲The source of the core team of Yourui Pharmaceutical: Tianyancha
After years of development, Yourui Pharma has 5 commercial products, of which the first commercial product is the fully imported polysaccharide iron supplement - Lifeneng, which was acquired in 2019, with sales of about 300 million yuan
in 2021.
In 2021, in order to further upgrade its commercialization capabilities and expand its product pipeline, Yourui Pharma also spent hundreds of millions of yuan to complete the acquisition of 100% equity of Zhongjian Pharmaceutical, including three mature products in the field of emergency care, such as issucigi and Iromedine, and one product under development that is in the stage of market review
.
At present, based on the unique "commercial marketing + cooperative R&D" two-wheel drive model, Yourui Pharma has a late-stage clinical pipeline and commercial-stage asset portfolio
in respiratory, first aid, iron deficiency anemia and pain management.
In the respiratory field, Yourui Pharma focuses on respiratory diseases such as chronic obstructive pulmonary disease (COPD), respiratory syncytial virus (RSV) vaccine, neonatal respiratory distress syndrome and allergic rhinitis, and has passed the license
In mode layout 4 products
under development.
under development.
▲The R&D pipeline (respiratory part) of Yourui Pharma Source: The company's official website
Among them, Ensifentrine, a blockbuster product under development, is a new PDE3 and PDE4 dual-target inhibitor of its kind in the world, which enables it to achieve bronchodilation and anti-inflammatory effects at the same time with a single compound, and is currently conducting phase III clinical trials in China for the treatment of COPD patients
.
The product was invested by U.
S.
listed company Verona in June 2021 with a total value of US$290 million
Pharma was introduced and has exclusive rights
to develop and commercialize in Greater China.
.
Another blockbuster product that has attracted much attention, the MVA-BN-RSV vaccine, was introduced from Bavarian in March 2022 for more than US$200 million
Nordic has development and commercialization interests
in China, South Korea and select Southeast Asian countries.
According to reports, the MVA-BN-RSV vaccine uses five different RSV antigens, which have been awarded breakthrough therapy designation by the US FDA since this year, and have been granted priority drug qualification (PRIME) by the European Medicines Agency (EMA) for active immunization of adults aged 60 or above to prevent lower respiratory tract diseases
caused by RSV.
.
Based on positive preliminary results from a phase II clinical trial published earlier, the MVA-BN-RSV vaccine has shown up to 79% efficacy
in preventing symptomatic RSV infection.
In April this year, the vaccine launched a global, randomized, double-blind phase III trial (VANIER study) and was approved for clinical trials
in China on November 14.
in China on November 14.
20 billion track, the number of asthma/COPD patients exceeds 140 million, and the domestic replacement rate of inhaled preparations is low
20 billion track, the number of asthma/COPD patients exceeds 140 million, and the domestic replacement rate of inhaled preparations is lowThe respiratory field not only has a large patient population, but also has significant characteristics
such as high technical barriers and difficulty in imitation.
According to statistics, chronic respiratory diseases are the third leading cause of death from chronic diseases among Chinese residents, second only to cardiovascular and cerebrovascular diseases and tumors
.
Asthma and chronic obstructive pulmonary disease (COPD) are the most common and have a large
patient base.
patient base.
According to the 2019 Lancet study, the prevalence of asthma among people aged 20 and above in China is 4.
2%, with a total of 45.
7 million patients; The prevalence of COPD in people aged 20 years and older is 8.
6%, with a total of nearly 100 million cases
.
In addition, there are 250 million allergic rhinitis patients
in China.
7 million
, and the total number of cases reached nearly 100 million.
250 million patients with allergic rhinitis
However, due to the long course of respiratory diseases, the poor autonomy of patients at the time of onset, coupled with the high technical barriers of respiratory drugs and the difficulty of imitation, the current choice of therapeutic drugs is limited, but it also means that there is a large unmet clinical need
.
.
From the perspective of market prospects, according to data, the global asthma/COPD drug market size in 2019 exceeded 20 billion US dollars, and the Chinese market size was about 20 billion yuan.
At present, because there is no drug to cure asthma disease, it can only be controlled and relieved, and the clinical administration mode is divided into oral administration and inhalation administration
.
Among them, because respiratory inhalants are inhaled into the lungs through the mouth and nose to alleviate the development of the disease, they have the advantages of small dosage, fast onset, small side effects, and suitable for long-term treatment, and are recommended by WHO as the preferred treatment for
asthma and chronic obstructive pulmonary diseases.
.
From the classification point of view, inhalation preparations can be divided into inhaled glucocorticoids (ICS), bronchodilators (β2 receptor agonists, anticholinergic antagonists) according to the active ingredients of the drug; According to the number of drugs contained in the preparation, it can be divided into unilateral preparations and compound preparations (including double and triple preparations).
According to the dosage form, inhalation preparations are generally divided into metered-dose inhalation aerosol (MDI), powder aerosol (DPI), nebulized inhalation solution (NEB) and spray (Spray), all of which have different characteristics and usage
.
From the perspective of type, the global market is mainly based on inhaled glucocorticoids/long-acting β2 receptor agonists (ICS/LABA) combination preparations, and the main therapeutic drugs in China are still mainly ICS unilateral preparations
.
In terms of dosage forms, powder nebulizers and aerosols that patients are more likely to use account for nearly 80% of the total global market, while nebulized inhalers account for 73%
of the Chinese market.
preparations.
Because most inhalation preparations are integrated with drugs and devices, the barriers to research and development and production are high and imitation is difficult, so that the localization rate of inhalation preparations in China is less than 10%, which is occupied by the three leaders of AstraZeneca, GlaxoSmithKline and Boehringer Ingelheim
.
.
However, with the expiration of the patents of the core compounds and inhalers of the respiratory preparation products of the original foreign-funded giants, domestic enterprises have intervened in the research and development of imitation, and it is expected to break the long-term monopoly of the original research in the future
.
Hengrui Pharmaceutical, Health Yuan, and China Biopharmaceutical accelerate domestic substitution
Hengrui Pharmaceutical, Health Yuan, and China Biopharmaceutical accelerate domestic substitutionSpecifically, Health Yuan, China Biopharmaceutical/Chia Tai Tianqing, and Hengrui Pharmaceutical are representative enterprises
in the domestic respiratory field.
in the domestic respiratory field.
Health Yuan: At present, a number of respiratory drug products have been approved for marketing, of which 3 products (ipratropium bromide inhalation solution, budesonide suspension, compound ipratropium bromide solution) won the bid for the fifth batch of national centralized procurement, and 1 product (terbutaline sulfate atomization inhalation solution) won the bid for the seventh batch of national procurement
.
In addition, Health Yuan also has the first imitation and exclusive product in China - levalbutamol hydrochloride nebulized inhalation solution, and the first inhaled antibiotic in China - tobramycin inhalation solution (i.
e.
"Jianketo"
).
▲Health Yuan's inhalant product source: Minai.
com
In terms of research pipelines, Health Yuan covers various types of atomization solutions, aerosols and powder aerosols, and at present, the generic marketing applications of fluticasone propionate nebulized inhalation suspension, formoterol fumarate inhalation solution, budesonide inhalation aerosol are under review and approval; Salmeterol ticasone inhalation powder aerosol has started phase III clinical studies
.
China Biopharmaceutical: The respiratory field is mainly developed and sold by the subsidiary Chia Tai Tianqing, and a number of products such as budesonide suspension (Tianqing Suchang ®), tiotropium bromide powder mist inhaler (Tianqing Sulla), ® cloxexin tablets, fodostein tablets, montelukast sodium granules and other products have been approved for marketing
.
Among them, Tianqing Speedhang ® is the first domestic imitation of the original research AstraZeneca's budesonide suspension, which was approved in February 2020 and successfully won the bid for the fifth batch of national centralized procurement
.
.
In addition, as of the first half of 2022, the company has a total of 9 innovative drug candidates in the respiratory field in the clinical application and above development stage, and 20 biosimilar or generic drug candidates in the respiratory system field in the clinical application and above development stage, including 9 products in the marketing application stage
.
.
Hengrui Pharmaceutical: At present, there are two anesthesia inhalation preparations on the market, namely inhalation diflurane and inhalation sevoflurane, the latter is the first inhalation preparation that passed the consistency evaluation in China and the second inhalation preparation
approved in the United States.
In addition, Hengrui also has 3 respiratory products under development: SHR-1703, SHR-1906, SHR-1905, the indications are monotherapy for eosinophilic severe asthma, pulmonary fibrosis, asthma
.
【Reference】
【Reference】【Reference】
1.
"Interview with Yourui Pharmaceutical: How to create a cash "hematopoietic" textbook in the field of respiratory fine drugs? Arterial New Medicine, 2022-10-28
"Interview with Yourui Pharmaceutical: How to create a cash "hematopoietic" textbook in the field of respiratory fine drugs? Arterial New Medicine, 2022-10-28
2.
"20201230-Guotai Junan-Pharmaceutical Industry: Inhalation Preparations Tens of Billions of Blue Ocean, High-quality Tracks Need to Select Good Horses"
"20201230-Guotai Junan-Pharmaceutical Industry: Inhalation Preparations Tens of Billions of Blue Ocean, High-quality Tracks Need to Select Good Horses"
3.
Financial reports, announcements, and official websites of each company
Financial reports, announcements, and official websites of each company
