Hengrui Medicine Submits NDA for Second "Myopia Wonder Drug" in China

On February 18, Hengrui Pharma announced that its subsidiary, SUNCADIA, had received acceptance from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) of Atropine Sulfate Eye Drops (HR19034 Eye Drops). The indication sought for approval is to slow the progression of myopia in children aged 6 to 12 years with a spherical equivalent refraction of -0.50 D to -4.00 D (astigmatism ≤1.50 D and anisometropia ≤1.50 D).

This marketing application for listing is based on a randomized, double-blind, placebo-controlled, parallel-group Phase II/III clinical study (Study No. HR19034-301). The results demonstrated that the Company’s atropine eye drops (HR19034 Eye Drops) were significantly superior to the control group in terms of the primary endpoint, and exhibited favorable safety and tolerability profiles during long-term treatment in pediatric patients with myopia.

Hengrui Pharma’s recent approval signifies a major shift in the competitive landscape of the domestic low-concentration atropine market, breaking the monopoly previously held by Xingqi Eye Medicine.

Currently, the global prevalence of myopia is continuing to rise. It is projected that by 2050, the number of people with myopia worldwide will reach 4.758 billion, accounting for 49.8% of the total population. According to data from the National Health Commission of China, the prevalence of myopia among Chinese children and adolescents was 52.7% in 2020, with rates of 35.6% among primary school students, 71.1% among junior high school students, and 80.5% among senior high school students. Myopia is exhibiting trends toward earlier onset, higher severity, and a continuously increasing prevalence, while the prevalence of pathological myopia has also risen significantly. It is imperative to delay the progression of myopia and prevent the occurrence of pathological myopia.

Currently, there are various methods for correcting myopia in children, including spectacle lenses, contact lenses, orthokeratology lenses, and low-concentration atropine eye drops. Among these, low-concentration atropine eye drops have garnered significant attention for pharmacological intervention, with extensive clinical studies confirming their efficacy in effectively slowing the progression of myopia.

On March 11, 2024, Xingqi Eye Pharma received approval for the first atropine sulfate eye drops with a “National Drug Approval Number” in China, becoming the only approved prescription-grade product on the market. Its approved indication is to slow the progression of myopia in children aged 6 to 12 years, which significantly overlaps with the indication filed by Hengrui Pharma.

The approval of this product fills a gap in domestic medications for myopia control in children. Previously, as an in-house hospital preparation, the product had accumulated years of clinical data; it contributed over 10% of revenue in the first half of 2024, driving a year-on-year surge of 92.95% in the company’s net profit.

However, securities firms had predicted that Xingqi Eye Medicine’s revenue from atropine eye drops would reach RMB 1.5 billion in 2024, but actual performance fell far short of expectations. In the second and third quarters of 2024, revenue growth was primarily driven by this product, with estimated quarterly sales of only RMB 130–140 million; full-year revenue is likely to remain below RMB 500 million, marking a significant deviation from forecasts. Restrictions on the sale of in-house hospital preparations and insufficient patient education are key contributing factors.

Consequently, the industry has closely monitored which candidate will emerge as the second “blockbuster drug for myopia.” In January 2025, Zhaoko Ophthalmology’s simplified New Drug Application (NDA) for NVK002 was accepted, with the indication focused on slowing myopia progression in children.

Just one month later, Hengrui Pharma submitted its marketing authorization application. The “exclusivity period” for Xingqi Eye Medicine is now counting down, and the industry is poised to shift from a “single-player dominance” to a “multi-player competitive landscape.”

Driven by both policy incentives and clinical demand, the ophthalmic drug market remains a blue ocean. Public data shows that the market size of ophthalmic drugs in China exceeded RMB 40 billion in 2024, with a compound annual growth rate (CAGR) of 16% from 2019 to 2024.

Ophthalmic drugs represented by atropine are eyeing the device-dominated myopia market. In recent years, an increasing number of ophthalmic companies have rushed to lay out this product, resulting in numerous participants entering the field. Globally, atropine eye drops from companies such as Aspen (Australia), Entod (India), and Santen Pharmaceutical (Japan) have already been launched. In China, in addition to Xingqi Eye Medicine’s product being on the market, applications for NVK002 from Zhaoko Ophthalmology and HR19034 from Hengrui Pharma have been successively accepted.

In addition, products from more than 20 pharmaceutical companies, including Shapuaisi, Borui Medicine, Ocumension Therapeutics-B, and Qilu Pharmaceutical, have entered Phase III clinical trials, with indications covering myopia progression control and intermittent exotropia combined with myopia. The future approval of products from third-tier companies will further intensify price competition.

For Hengrui Pharma, the HR19034 ophthalmic solution utilizes Blow-Fill-Seal (BFS) integrated filling technology, with its single-dose, preservative-free design serving as a core competitive advantage. Its active ingredient, atropine sulfate, delays myopia progression by inhibiting axial elongation through antagonism of muscarinic acetylcholine M receptors. Compared to traditional multi-dose eye drops, the single-dose packaging not only avoids potential damage to the ocular surface caused by preservatives but also enhances medication safety, making it particularly suitable for long-term use in children.

When HR19034 eye drops were approved for clinical trials in 2019, Hengrui Pharma’s goal was to “become the first eye drop product in China and even globally for the prevention and control of myopia in children.” However, it was beaten to market by Xingqi Eye Medicine’s 0.01% atropine sulfate eye drops.

Although it was not the first product to gain approval, Hengrui Pharma, as a leading player in China’s pharmaceutical industry, holds significant advantages in production capacity reserves, channel coverage, and brand influence. If HR19034 eye drops receive smooth approval, its single-dose technology is poised to become a core selling point for differentiated competition.

Meanwhile, Hengrui Pharma is poised to generate synergies across its multiple pipelines in the ophthalmology sector, further strengthening its market position.

In the field of ophthalmology, Hengrui Pharma has deployed a portfolio of innovative and generic drugs, with indications covering dry eye disease, glaucoma, and other conditions. Currently, two generic products—diquafosol sodium eye drops and tafluprost eye drops—have been approved for marketing. The New Drug Application (NDA) for the Class 1 innovative drug SHR8058 eye drops is under review and is expected to be approved within 2025. The NDA for HR19034 eye drops, a Class 2 improved new drug, has been submitted, positioning the company to become the second domestic manufacturer to market this product.

However, in addition to facing competition from similar products, atropine eye drops must also contend with competition from in-house hospital preparations due to their low formulation barriers and relatively inexpensive raw materials. For instance, other concentrations, such as 0.015% atropine eye drops, are available at lower prices.

Furthermore, in the myopia management sector, numerous products with novel mechanisms are continually emerging, such as Grand Pharma’s innovative ophthalmic eye drop GPN00884. Compared with low-concentration atropine eye drops, this product does not cause mydriasis and avoids adverse reactions such as photophobia and reduced accommodation, thereby resulting in higher patient compliance.

Although Hengrui Pharma has laid a market foundation with two first-to-file generic drugs, doubts remain as to whether it can replicate its leading position in contrast agents and oncology drugs within the ophthalmology sector. The future competitive landscape for HR19034 eye drops is fraught with uncertainty. In the long run, leveraging its internationalization capabilities—such as advantages in production capacity and distribution channels—and participating in global market competition through overseas clinical trials and channel expansion may provide new opportunities and room for sustained growth in its ophthalmology business.