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Recently, Joincare Pharmaceutical Group Industry Co., Ltd. (600380.SH, hereinafter referred to as "Healthy Yuan") has undertaken the clinical trial of its newly declared arbidonium bromide inhalation powder, a Class 2 new drug, and is currently awaiting review. It is understood that there are currently no similar inhalation products on the market.

It is noteworthy that in March this year, AstraZeneca also submitted a Class 5.1 imported clinical application for arbidonium bromide powder inhaler, which is currently under review and approval. Whether the original research drug will be approved for import first or the domestic new drug will seize the opportunity is worth further attention.

For Healthy Yuan, which has been involved in the respiratory field for nearly ten years, it has previously declared 13 inhalation products for listing, with 4 already approved for production and deemed to have passed the review. Among them, the inhalation solution of combined ipratropium bromide and levosalbutamol hydrochloride inhalation solution are the first domestic generic drugs.

In fact, this is just a glimpse of the results of Healthy Yuan's continuous focus on R&D investment over the years.

Healthy Yuan was founded in 1992 and went public in 2001. After years of operation and development, it has become a comprehensive group company integrating the research, development, production, sales, and service of pharmaceuticals and health products. Regarding its own positioning, Healthy Yuan stated, "We always adhere to technological innovation as our strategic foundation and aim to build a high-end barrier complex preparation technology platform. We strive to gradually grow into an innovative pharmaceutical enterprise with industry influence under the dual drive of innovation and high-barrier technology platforms."

Along the way, Healthy Yuan has been committed to using technology to create a healthy life, focusing on the real needs of patients. In the wave of building a "Healthy China," Healthy Yuan is expected to embrace new development opportunities with its innovative genes.

Breaking Through "Bottleneck" Difficulties

Currently, common drug delivery methods for treating respiratory diseases include inhalation, oral administration, intravenous injection, and transdermal administration. Studies have shown that compared with systemic administration, inhalation preparations have the advantages of achieving higher concentrations in the respiratory tract, faster onset of action, and fewer adverse reactions, and have been recognized and recommended by the World Health Organization. However, in China's hundreds of billions of yuan inhalation preparation market, the domestic production rate is less than 10%. For a long time, multinational pharmaceutical giants have occupied more than 90% of the Chinese market for inhalation preparations. This is because the difficulty of imitation of inhalation preparations is extremely high, and China's respiratory drug field faces "bottleneck" development constraints such as high technical barriers, high costs, and high risks. Therefore, this market is also known in the industry as "the most high-end and difficult sub-field in the generic drug field."

In order to accelerate the reversal of the long-term dominance of imported brands in China's inhalation preparation market, the domestic substitution process of inhalation preparations is in full swing. As early as 2013, Healthy Yuan began to continuously develop in the respiratory field and is one of the first domestic companies to establish an inhalation drug delivery technology platform.

Founded in 1992, Healthy Yuan, after years of operation and development, has become a comprehensive pharmaceutical enterprise covering multiple fields, including chemical preparations, traditional Chinese medicine preparations, chemical raw materials and intermediates, diagnostic reagents and equipment, and health products. Healthy Yuan has focused on building four major R&D platforms: monoclonal antibodies, inhalation preparations, lipid microemulsions, and sustained-release microspheres. Among them, the company's layout in the inhalation preparation sector is relatively leading, and after gradually entering the product harvest period, four inhalation preparations have been approved for listing.

In 2020, Healthy Yuan's R&D investment totaled 1.261 billion yuan, a year-on-year increase of 18.25%. During the reporting period, the company had 5 new products approved for listing, mostly high-barrier complex preparations, including 3 inhalation preparation varieties (5 specifications) and 1 lipid microemulsion variety (2 specifications).

At the same time, with the entry of many of Healthy Yuan's innovative drugs into the clinical stage, such as tobramycin inhalation solution, levosalbutamol hydrochloride ipratropium inhalation solution for inhalation preparations, aripiprazole microspheres injection for sustained-release microspheres, and IL-17A/F and A-01 for monoclonal antibodies, respiratory products and innovative drugs will be important sources of the company's future performance growth.

With favorable factors such as the price advantages brought by the "4+7" centralized procurement of drugs and the increase in product sales driven by the successive listing of generic respiratory inhalation preparations, domestic companies are expected to consolidate their competitive advantages and continuously improve their market share.

2020 was a year of significant policy implementation in the pharmaceutical industry. On the one hand, China's market policy environment is relatively special. Regarding domestic inhalation preparation review policies, it was not until December 16, 2020, that the Center for Drug Evaluation of the National Medical Products Administration issued the "Guidelines for Bioequivalence Studies of Oral Inhalation Preparations for Generic Drugs." Before that, although China had also issued policies encouraging the research and development, standardization, and accelerated listing and sales of inhalation preparations, due to the uncertainty of input-output in this field, most companies remained in a wait-and-see state. It is understood that there are currently few leading companies in China that have entered the inhalation preparation field, and Healthy Yuan is one of the very few companies that can meet the above conditions.

The "Healthy China Action (2019-2030)" points out that chronic non-communicable diseases have become the leading cause of death, representing the largest disease burden in China, and indicates that the prevention and control of chronic respiratory diseases should be elevated to a national strategy.

On the other hand, 2020 not only saw the release of the new version of the "Chinese Pharmacopoeia," but the work of organizing national drug volume-based procurement and expanding its scope continued to deepen, and adjustments were made to the medical insurance catalog. For China's inhalation preparation market, the direction of the policy environment is crucial. If new products can be included in medical insurance, it will help companies accelerate the increase in product sales; for overseas products with smaller scales, if they are exclusively approved and included in medical insurance in China, they are also expected to open up a larger market in China. For domestic companies to succeed in breaking through in this blue ocean of inhalation preparations, they also need strong R&D capabilities and a forward-looking strategy of early layout.

The "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2020)" (hereinafter referred to as the "National Medical Insurance Catalog") shows that levosalbutamol hydrochloride nebulization inhalation solution (Lishutong) under Healthy Yuan, through negotiations, has become the only domestic inhalation preparation included in this National Medical Insurance Catalog, and there are no restrictions on medical insurance payment categories.

In fact, this is just a glimpse of the results of Healthy Yuan's continuous focus on R&D investment over the years.

It is reported that since 2019, the four inhalation preparations launched by Healthy Yuan have all obtained high-quality certification: the inhalation solution of combined ipratropium bromide (Shutanlin) became the first inhalation preparation approved for listing since the country launched the consistency evaluation of generic drugs; the inhaled budesonide suspension (Wushu) became the only enterprise product with both large and small specifications approved, with the children's specification being the first domestic generic drug approved; levosalbutamol hydrochloride nebulization inhalation solution (Lishutong), through priority review, became the first and only domestic short-acting β-agonist approved, and was the only domestic inhalation preparation included in the 2020 National Medical Insurance Catalog; ipratropium bromide inhalation solution (Liwu'an), along with Wushu and Shutanlin, was listed and recommended in the new version of the guidelines.

Currently, HealthGen's existing product portfolio covers all categories of asthma and COPD inhalation therapies, breaking the monopoly of a few multinational companies and demonstrating the rapid rise of the domestic market in this field.

Reform and Innovation Compose a Splendid Chapter

Looking back at the tide of history and development. In 1992, Deng Xiaoping's important speeches during his southern tour to Shenzhen and other places triggered a new wave of reform and opening up.

Located at the forefront of the Pearl River Delta, Shenzhen became China's first Special Economic Zone in 1980, shouldering the important responsibility of being a window for reform and opening up. After the 1990s, Shenzhen focused on developing high-tech industries, and it was on this basis, coupled with the open economic environment, that medical devices, biomedicine, precision medicine, and other medicine-related industries took root and grew in Shenzhen.

Enterprises are the source of vitality in a city's economic context, and the vigorous development of the country is the result of the creativity and cohesion of various cities and enterprises. Born under the spring breeze of reform in 1992, HealthGen seized the opportunity for development. Under the strong leadership of Zhu Baoguo, HealthGen continuously broke the old order of the pharmaceutical industry, experimented with new production technologies, and devoted itself to the great health industry for many years. It successively acquired Haibin Pharmaceutical and Lizhu Group, and with the help of the capital market, successfully built a comprehensive pharmaceutical enterprise including two listed companies. Data shows that Lizhu Group has more than 400 varieties of raw materials, chemical drugs, traditional Chinese medicines, biological drugs, and diagnostic reagents, with more than 90 varieties in production and sales, covering areas such as digestion, cardiovascular and cerebrovascular diseases, reproductive endocrinology, anti-infection, and anti-tumor.

The pace of development has never stopped. Since 2010, HealthGen has embarked on a new milestone, actively engaging in the biopharmaceutical industry, with the mission of "For Health, For Tomorrow," the vision of "Making Good Medicines with Care," and the core values of "People-Oriented, Craftsmanship Quality, Innovation and Pragmatism, Cooperation and Sharing," focusing on the great health pharmaceutical field; in 2013, it officially established Shanghai Fanyu Health Pharmaceutical Technology Co., Ltd., proactively deploying the inhalation preparation track; in 2015, it began to deploy the Internet and other medical and health industries, always adhering to innovation-driven development.

Along the way, HealthGen has adhered to technology-driven creation of healthy lives, based on the real needs of patients. In the wave of building a "Healthy China," HealthGen's R&D capabilities have been continuously verified, and its development strategy focusing on inhalation preparations has improved the medication conditions in China's inhalation administration field. In the tide of the times, HealthGen has written a satisfactory "innovation answer sheet" in the great health cause by wholeheartedly making good medicines.

Source: Sina Finance