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Shisi Pharmaceutical Group Accelerates Its Entry into a New Stage of High-Quality Development

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发布时间：2020-04-01

【概要描述】 On March 30, Shisiyao Group (02005.HK) announced its 2019 annual results, reporting full-year sales revenue of HK$4.636 billion, up 10.9% year on year (or approximately 15.3% in RMB terms); and net profit of HK$1.136 billion (or about RMB 1.00 billion), an increase of 24.6% year on year (or approximately 29.6% in RMB terms). In 2019, Shisiyao Group focused on strengthening market penetration in key provinces and maintaining and consolidating its competitive advantages. The company also prioritized optimizing its product mix, ramping up sales of therapeutic intravenous solutions, thereby ensuring robust production and sales performance across its product portfolio.

Shisi Pharmaceutical Group Accelerates Its Entry into a New Stage of High-Quality Development

On March 30, Shisi Pharmaceutical Group (02005.HK) announced its 2019 annual results, reporting full-year sales revenue of HK$4.636 billion, up 10.9% year on year (or approximately 15.3% in RMB terms); and net profit of HK$1.136 billion (or about RMB 1.00 billion), an increase of 24.6% year on year (or approximately 29.6% in RMB terms).

In 2019, Shisi Pharmaceutical Group focused on strengthening market penetration in key provinces and maintaining and consolidating its competitive advantages. The company also prioritized optimizing its product mix by increasing sales of therapeutic intravenous solutions, thereby ensuring robust production and sales performance and continuing to rank among the fastest-growing companies in terms of both output and revenue in the large-volume parenteral solutions industry. Throughout the year, sales of the company’s flagship large-volume parenteral products rose by approximately 5.6% year on year, while the share of therapeutic intravenous solutions in total large-volume parenteral sales increased to 22.3%, a year-on-year rise of 2.6 percentage points.

During this period, ampoule injectable products posted rapid growth. Full-year sales of ampoule products reached HK$392 million, representing a year-on-year increase of 208%. In recent years, newly approved products have gradually secured market access in various regions, and the Group has intensified efforts to promote the sales of these new products across all provinces. Notably, moxifloxacin hydrochloride sodium chloride injection has achieved market access in 22 provinces and is now sold in 21 of them. Fiscal year 2019 marked the product’s first full year of sales, during which sales successfully surpassed the HK$100 million milestone. With ongoing progress in market access and hospital penetration, this product is expected to maintain its strong growth momentum going forward.

During this period, Shisi Pharmaceutical Group further enhanced its technological innovation capabilities and gradually established a comprehensive, scientific, and well-defined technological innovation system. In 2019, the company successfully completed the re-evaluation for the National Enterprise Technology Center, the National Demonstration Enterprise for Technological Innovation, the National–Local Joint Laboratory, and the Postdoctoral Research Station. It also submitted applications to the China National Intellectual Property Administration for the China Patent Award and the designation as a National Intellectual Property Advantage Enterprise, which has played a crucial role in ensuring that the company’s technological innovation capacity and level continue to rank among the top tier nationwide.

The Phase I new drug project NP-01 of Shisiyao Group has been submitted to the National Medical Products Administration for review, marking the company’s first innovative drug application and signaling a strategic shift from purely generic development to a new stage that integrates generic and innovative R&D. In the area of innovative drugs, the Class 1 anti-tumor candidate NP-01 is expected to commence Phase I clinical trials in the first half of 2020; the Class 1 anti-liver-fibrosis candidate AND-9 has fully entered preclinical pharmacological and toxicological studies, with a Phase I clinical trial registration application anticipated within the year. A series of independently developed compounds for the treatment of pulmonary arterial hypertension have so far identified three highly active lead compounds, which are currently undergoing systematic preclinical research; the novel anti-epileptic compound QO-83 has demonstrated promising drug-like properties in preliminary animal studies; and the Class 2 chemically synthesized anti-tumor agent miblomide is proceeding as planned with pharmacodynamic and safety evaluations, with a clinical trial registration application expected to be submitted within the year.

In addition, Shisi Pharmaceutical Group has continuously achieved breakthroughs in R&D. Throughout the year, the company secured 13 marketing approvals for generic drugs and 2 approvals for bioequivalence evaluations. Among these, tirofiban hydrochloride sodium chloride injection, a cardiovascular medication indicated for the clinical treatment of acute coronary syndromes, is a therapeutic agent with significant potential for widespread clinical adoption and is poised to become a key driver of the company’s performance growth. The approval of a series of peritoneal dialysis solutions, when combined with the company’s existing hemodialysis products, will enable the company to enter the dialysis market, which offers substantial room for future growth. Hydroxyethyl starch 130 sodium chloride injection is expected to carve out a strong position in the volume-expansion and anesthesia markets. Furthermore, three specifications of ambroxol ampoules have expanded the company’s respiratory product portfolio. In addition, fluconazole tablets in both 50 mg and 150 mg strengths have passed bioequivalence evaluations, with the 150 mg formulation being the first of its kind in China to do so, thereby positioning it to capitalize on favorable market opportunities in upcoming national drug procurement tenders.

Looking ahead to 2020, Shisi Pharmaceutical Group will maintain its leading position in the large-volume parenteral solutions market. Despite the impact of the COVID-19 pandemic on large-volume parenteral sales in the first quarter of this year, the company aims to achieve an overall year-on-year increase of approximately 3.56% in sales volume across all categories of such products and further expand the share of therapeutic infusion products in total sales. The company will also strengthen marketing efforts for its core therapeutic infusion products, such as moxifloxacin, with the goal of building on last year’s breakthrough of RMB 100 million in sales to achieve a doubling of annual sales. In addition, the company will continue to advance new-product development and the implementation of bioequivalence evaluations.

In addition, Shisi Pharmaceutical Group will adhere to a development strategy that integrates generic and innovative drug R&D, with a focus on injectable formulations. The company will maintain its technological and product leadership in China’s large-volume parenteral solutions market while comprehensively advancing the development of new therapeutic injectables, with particular emphasis on therapeutic areas such as chronic diseases, respiratory disorders, cardiovascular conditions, emergency and anesthesia medications, antipyretic analgesics, and novel anti-infective agents.

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