Original Canson Minnet
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At the beginning of 2022, the good news of Hongri Pharmaceutical was frequently spread: the KB project of 1 new drugs was qualified by the FDA fast track; the first heparin preparation enoxaparin sodium injection was mass-produced and treated as the same evaluation; the net profit in 2021 was pre-increased by 10% to 30%, and the chinese medicine formula granules and hebijing injection were the main growth force. The company continues to increase investment in research and development, 5 new drugs of class 1 are under research, the second heparin preparation of natraparin calcium injection, the first anti-tumor class 1 new drug p-toluenesulfonamide injection is expected to be approved for listing in 2022.
Formula granules, exclusive injections are on sale! Net profit pre-increase 10% to 30%
Annual net profit of Hongri Pharmaceutical (unit: 100 million yuan)
On January 28, Hongri Pharmaceutical released its 2021 annual performance forecast, and it is expected that the net profit attributable to shareholders of listed companies in 2021 will be 631 million yuan to 746 million yuan, an increase of 10.05% to 30.10% over the same period of the previous year.
Founded in 1996, Hongri Pharmaceutical co., Ltd. focuses on research and innovation in the fields of critical disease, oncology and immunity, cardiovascular and cerebrovascular diseases, respiratory system, and neurodegenerative diseases. The company's business layout can be roughly divided into finished drugs, Chinese medicine formula granules, raw materials and excipients, medical devices, medical and health services and pharmaceutical equipment intelligent supply chain and other businesses. In 2009, Hongri Pharmaceutical was listed on the ChiNext board of the Shenzhen Stock Exchange, and was the first batch of listed enterprises on the ChiNext board in China.
For the reasons for the pre-increase in performance, Hongri Pharmaceutical said that the Traditional Chinese medicine formula granule business continued to strengthen the national production capacity layout, continued to improve the market coverage and penetration rate of the stock market, and achieved greater growth in revenue and profits compared with the same period last year; the sales volume of hebijing injection, the main product of the finished drug business, increased steadily; the raw materials and excipients business, benefiting from the restructuring of the international pharmaceutical industry chain, the company seized market opportunities, actively promoted product optimization, and promoted overseas market share improvement.
Chinese medicine formula granules and drinking tablets are the performance of Hongri Pharmaceutical, accounting for half of the revenue. In recent years, the sales scale of Red Sun Pharmaceutical's traditional Chinese medicine formula granules and tablets has been more than 2 billion yuan, and the sales revenue in 2020 will be 2.991 billion yuan, accounting for 46.09% of the total revenue; in the first half of 2021, the sales revenue exceeded 1.8 billion yuan, an increase of 49.56% year-on-year, accounting for 51.64% of the total revenue.
As one of the earliest national pilot enterprises of Chinese medicine formula granules, Hongri Pharmaceutical Kangrentang chinese medicine formula granules have more than 600 kinds, basically covering all the varieties with the highest clinical use frequency of traditional Chinese medicine. With the end of the pilot, the scope of application of Traditional Chinese medicine formula granules has been expanded from "chinese medicine hospitals above secondary hospitals" to all medical institutions, the market space has been greatly increased, and the market scale is expected to reach a new high. Despite the increase in the number of entrants, as a pioneer in this market, Hongri Pharmaceutical has significant barrier advantages.
Hebijing injection is an exclusive variety of Hongri Pharmaceutical, and is currently the only national class II new drug approved by the State Food and Drug Administration for the treatment of sepsis, multi-organ dysfunction syndrome and severe and critical new crown pneumonia. In December 2021, Hebijing Injection continued to be included in the Category B scope of the National Medical Insurance Drug Catalogue through medical insurance renewal negotiations. According to data from the intranet, in the first half of 2021, the sales of terminal hebijing injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) exceeded 300 million yuan, an increase of 34.38% year-on-year.
6 major varieties have been reviewed! Enter the 10 billion heparin market
On January 11, Hongri Pharmaceutical issued an announcement that the company's enoxaparin sodium injection, which was reported as a generic 4 type, was approved for listing and was deemed to have passed the consistency evaluation. Previously, Heparin and Qianhong Pharmaceutical's Enoxaparin sodium injection has been evaluated, and Hongri Pharmaceutical is the third enterprise to evaluate the product.
Up to now, Hongri Pharmaceutical has passed/treated 6 varieties of consistency evaluation, including enoxaparin sodium injection, pramipexole hydrochloride extended-release tablets, pramipexole hydrochloride tablets, sagrel hydrochloride tablets, fasudil hydrochloride injection, moxifloxacin hydrochloride sodium chloride injection, etc. Among them, moxifloxacin hydrochloride sodium chloride injection and sagrel hydrochloride tablets were the first to be evaluated.
Hongri Pharmaceutical passed/treated the same through consistency evaluation of varieties
Source: MED2.0 China Drug Review Database
Among the 6 evaluated varieties, four varieties, such as moxifloxacin hydrochloride sodium chloride injection, pramipexole hydrochloride extended-release tablets, pramipexole hydrochloride tablets, and fasudil hydrochloride injection, have been successively included in the collection. Hongri Pharmaceutical's moxifloxacin hydrochloride sodium chloride injection won the bid for the third batch of collection, obtaining market share in 16 provinces and cities, and fasudil hydrochloride injection won the bid for the fifth batch of collection, obtaining market share in 7 provinces and cities.
Enoxaparin sodium injection is the first heparin drug approved for marketing in Hongri Pharmaceutical, marking the company's official entry into the heparin market and further enriching the company's product line. According to data from the intranet, the domestic market size of heparin drugs has continued to expand in recent years, with terminal sales of public medical institutions in China exceeding 10 billion yuan in 2020. Among them, the sales of Enoxaparin sodium injection exceeded 2.3 billion yuan, which is the leading variety in the heparin drug market.
In addition, The 4-class listing application for the imitation of Natraparin calcium injection of Hongri Pharmaceutical is under review and is expected to be approved for listing in 2022. According to data from the Intranet, in 2020, the sales of Natraheparin calcium injection at the terminal of China's public medical institutions exceeded 1.3 billion yuan, an increase of 10.46% year-on-year; in the first half of 2021, its sales exceeded 1 billion yuan, an increase of 23.82% year-on-year. At present, there are 6 approved enterprises in China for natraparin calcium injection, only Tianjin Pharmaceutical is evaluated, and Hongri Pharmaceutical will sprint to the second one.
5 innovative drugs shine! The first new class 1 drug on the market can be expected
In recent years, Hongri Pharmaceutical has continued to increase its innovation efforts, and independent research and development innovation and foreign cooperation model innovation are the company's current innovative two-wheel drive mechanism. At present, Hongri Pharmaceutical has 5 new drug projects in the research of class 1.1, including p-toluenesulfonamide injection (PTS), ammonium mesylate kuccamide B (KB) for injection, emdifen tablets, anti-hepatitis C drugs, ML4000.
Hongri Pharmaceutical is mainly researching innovative drugs
Source: Intranet database, company announcements
P-toluenesulfonamide injection was developed by Zhong Nanshan, an academician of the Chinese Academy of Engineering and a well-known medical expert, for the treatment of central non-small cell lung cancer with severe airway obstruction. P-toluenesulfonamide injection was first submitted as early as May 2014, and then voluntarily withdrew the registration application due to the "722" clinical data self-examination; the listing application was submitted again in January 2018, and then it was included in the priority review on the grounds of "innovative drugs with obvious therapeutic advantages", and is expected to be approved for listing in 2022. According to data from the intranet, the domestic market for anti-tumor drugs has continued to expand in recent years, and the terminal sales of public medical institutions in China will exceed 100 billion yuan in 2020, with a broad market space.
Calciumamine B mesylate for injection is currently the only dual-target bacterial pathogen-related molecular antagonist in the world, which is a drug for the treatment of sepsis developed with LPS and CpG DNA as dual targets, and is under clinical research in the IIb stage. On January 4, 2022, Hongri Pharmaceutical announced that picolamide B for injection has been granted a fast-track qualification by the US FDA, and the product has been approved for Phase II clinical trials in the United States in 2021, and obtaining FDA fast-track qualification indicates that it has the potential to address existing unmet clinical needs.
Emudifine tablets are the first approved clinical oral PD-L1 small molecule inhibitor in China, which has obvious advantages such as oral administration, strong patient compliance, and low cost to avoid adverse reactions caused by macromolecular drugs compared with the monoclonal antibodies for injection of the same target that are currently approved for marketing. At present, 4 PD-L1 monoclonal antibodies have been approved for listing in China, including AstraZeneca's dovalibizumab, Roche's altelizumab, Enverizumab of Idea Kangrui, and Sugli mab of Cstone Pharmaceuticals, all of which are macromolecular biological drugs. According to the financial report, AstraZeneca's duvallizumab sales revenue was $2.412 billion in 2021, an increase of 16% year-on-year, and Roche's atenizumab sales revenue was CHF 3.3 billion, an increase of 24% year-on-year.
Data source: Intranet database, company announcements
Note: As of February 10, if there is any omission, welcome to correct!