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At the beginning of the year, HealthGen released its 2021 annual performance forecast, predicting a net profit attributable to shareholders of listed companies of 1.255 billion to 1.367 billion yuan, a year-on-year increase of 12% to 22%. The main reason for the change in performance is the significant sales growth of the chemical preparation sector during the reporting period. Sales in key advantageous areas such as respiratory, digestive, gonadotropin, and mental health experienced sustained and rapid growth. In addition, the profitability and proportion of high-end specialty raw materials in the raw material medicine sector steadily increased, ensuring the steady growth of the company's overall performance.

HealthGen Pharmaceutical Group was founded on December 18, 1992, and listed on the Shanghai Stock Exchange in June 2001. It is an innovative and research-oriented comprehensive pharmaceutical group. It owns two large listed companies, HealthGen and Lizhu Pharmaceutical, and its subsidiaries include Lizhu Group, Lizhu Monoclonal Antibody, Haibin Pharmaceutical, Tai Tai Pharmaceutical, and Fangyu Health.

After years of development, the company's products cover biological drugs, prescription drug preparations, raw materials, health products, OTC drugs, diagnostic reagents and equipment, and have established a certain market advantage in multiple therapeutic areas such as respiratory, anti-infection, assisted reproduction, digestive, mental health, and tumor immunity.

The company adheres to research and development innovation as its driving force, focusing on the research and development of innovative drugs and high-barrier complex preparations. It has a clear product R&D pipeline, focusing on product lines in the fields of antimicrobials, anti-tumor, gonadotropins, digestion, nerves, and respiration. In recent years, the company has continued to increase its R&D investment, focusing on the construction of technology platforms such as inhalation administration, antibody technology, sustained-release microspheres, and lipid microemulsions, continuously improving its R&D competitiveness. In the first three quarters of 2021, the company's R&D expenses reached 959 million yuan, a year-on-year increase of 37.85%.

HealthGen's inhalation preparations have seen a significant acceleration in volume after the national centralized procurement, making a huge contribution to the company's 2021 annual performance. In recent years, HealthGen has increased its R&D investment in inhalation preparations, mainly for the treatment of respiratory diseases. The inhalation preparation product line is becoming increasingly rich, laying a solid foundation for the strategic goal of building a "leading domestic inhalation preparation enterprise".

Currently, the company's respiratory inhalation preparation sector has four products (seven specifications) approved for marketing, including levosalbutamol hydrochloride nebulization solution, combined ipratropium bromide inhalation solution, ipratropium bromide inhalation solution, and budesonide suspension for inhalation. Among them, levosalbutamol hydrochloride nebulization solution has entered the national medical insurance catalog through negotiations and achieved rapid coverage and sales growth after the implementation of medical insurance in March 2021; the other three products were successfully selected in the fifth batch of national centralized procurement, with significant volume increase and accelerated commercialization.

Data from MiNet shows that in 2020, the sales of anti-asthma and COPD drugs in China's public medical institutions (including urban public hospitals, county-level public hospitals, urban community centers, and township health centers) exceeded 20 billion yuan, with inhalation preparations accounting for as high as 70% of the market share and showing a year-on-year upward trend.

Sales of anti-asthma and COPD drugs in China's public medical institutions (Unit: 10,000 yuan)

Source: MiNet China Public Medical Institution Terminal Competition Pattern

It is worth noting that the domestic anti-asthma and COPD drug market has long been dominated by foreign companies, with AstraZeneca, GlaxoSmithKline, and Boehringer Ingelheim accounting for nearly 60% of the market share. There is huge potential for domestic companies to replace them in the market.

With the continuous advancement of the pipeline, HealthGen's inhalation preparation product line will usher in a period of intensive harvest. Acetylcysteine inhalation solution, terbutaline nebulization solution, tobramycin inhalation solution, and formoterol fumarate inhalation solution, which have been reported for production, are expected to be approved for marketing in 2022. Among them, tobramycin is expected to become China's first inhaled antibiotic.

HealthGen's inhalation agents expected to be approved for marketing in 2022

Lizhu Group's existing products involve gonadotropin, digestive tract, mental health, anti-infection, and traditional Chinese medicine preparations. Each therapeutic area has its representative products, such as leuprolide acetate microspheres for injection, esomeprazole series products, fluvoxamine maleate tablets, voriconazole for injection, and antiviral granules.

After years of market cultivation, Lizhu Group's innovative drug esomeprazole series products and high-barrier complex preparation leuprolide acetate microspheres for injection have become blockbuster products with over 1 billion yuan in sales. Among them, the sales revenue of leuprolide acetate microspheres for injection reached 1.176 billion yuan in 2020, a year-on-year increase of 27.01%; the sales revenue in the first half of 2021 was 818 million yuan, a year-on-year increase of 52.49%; the sales revenue of the esomeprazole series reached 1.766 billion yuan in 2020, a year-on-year increase of 81.20%; and the sales revenue in the first half of 2021 was 1.531 billion yuan, a year-on-year increase of 130.64%.

Currently, Lizhu Group focuses on the research and development of innovative drugs and high-barrier complex preparations.

On February 24, Lizhu Group announced that its Class 1 new drug LZ001 tablets have been approved for clinical trials. LZ001 tablets are a new generation of tyrosine kinase inhibitors intended for the treatment of advanced solid tumors, and are the company's first Class 1 new drug approved for clinical trials this year. Data from MiNet shows that in 2020, the sales of protein kinase inhibitors in China's public medical institutions exceeded 26 billion yuan, a year-on-year increase of 30%.

The company's microsphere pipeline is also continuously advancing, with seven main products under research. Among them, curpulirin acetate microspheres for injection (1-month sustained release) have submitted a marketing application; leuprolide acetate microspheres for injection (3-month sustained release) have completed Phase I clinical trials; and aripiprazole microspheres for injection (1-month sustained release) have started Phase I clinical trials.

Lizhu Group's microsphere products under research

It is worth mentioning that Lizhu Group's injection of Cupropilin microspheres is expected to become the first domestic product. Currently, only two Cupropilin microsphere preparations have been approved for import in China, from Ipsen of France and Huiling Pharmaceutical respectively. Data from MiNet shows that in 2020, the sales of Cupropilin microsphere preparations in China's public medical institutions exceeded 1 billion yuan, and in the first half of 2021, sales exceeded 600 million yuan, an increase of 41.34% year-on-year.

Lizhu Monoclonal Antibody is a high-tech enterprise focusing on the development of globally leading innovative macromolecular drugs, initiated by Lizhu Pharmaceutical Group and Healthyuan Pharmaceutical Group, established in July 2010. The company focuses on the fields of tumors, immune diseases, and assisted reproduction, with research products including recombinant proteins, antibodies, vaccines, and CAR-T cell therapy. Among them, the injection of recombinant human chorionic gonadotropin has been approved for marketing, and the injection of recombinant humanized anti-human IL-6R monoclonal antibody (Tocilizumab injection) has been submitted for marketing, with more than 10 varieties at different stages.

Recombinant human chorionic gonadotropin injection is an assisted reproductive drug, and is the first domestic imitation of Merck Serono's recombinant human chorionic gonadotropin (Ezego). Data from MiNet shows that in 2020, the sales of recombinant human chorionic gonadotropin in China's public medical institutions reached nearly 60 million yuan. It is worth mentioning that this product will form a synergistic effect with Lizhu Group's already marketed injection of Leuprolide microspheres, injection of urinary follicle-stimulating hormone, injection of urinary luteinizing hormone, and injection of chorionic gonadotropin, etc., which are used for assisted reproduction.

The recombinant humanized anti-human IL-6R monoclonal antibody injection is a biosimilar of Roche's Tocilizumab, and both Baoyatai and Lizhu Monoclonal Antibody have submitted marketing applications, competing for the first domestic Tocilizumab biosimilar. According to Roche's financial report, in 2021, the sales revenue of Tocilizumab injection (Actemra) was 3.562 billion Swiss francs (approximately US$3.899 billion, based on the average exchange rate in 2021).

Among the more than 10 varieties at different R&D stages, the recombinant anti-human IL-17A/F humanized monoclonal antibody injection has started Phase II clinical trials; the recombinant tumor enzyme-specific interferon α-2b Fc fusion protein and recombinant human follicle-stimulating hormone injection have started Phase I clinical trials; the injection of recombinant humanized anti-PD-1 monoclonal antibody has started Phase Ib/II clinical trials; and the sequential enhanced Phase III clinical trial of the recombinant novel coronavirus fusion protein vaccine (V-01) has obtained key interim data and is preparing to apply for conditional marketing.

Data source: MiNet database, company announcements

From: MiNet