The competition in the field of atropine sulfate, known as the "miracle drug for myopia", is becoming increasingly fierce. After Zhaoke Ophthalmology (06622. HK), the drug marketing authorization application for HR19034 eye drops under Hengrui Pharmaceutical (600276. SH) has been accepted by the National Medical Products Administration, and the exclusive situation of Xingqi Eye Medicine (300573. SZ) may be broken. In addition, several pharmaceutical companies have entered phase 3 clinical trials for atropine sulfate eye drops suitable for adolescent myopia.

This evening, Hengrui Pharmaceutical announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received a "Notice of Acceptance" issued by the National Medical Products Administration. The company's application for marketing authorization for HR19034 eye drops has been accepted by the National Medical Products Administration.

Hengrui Medicine stated in the announcement that HR19034 eye drops are a single dose eye drop developed by the company using B/F/S three in one filling technology. Its active ingredient is atropine sulfate, which does not require preservatives and can competitively antagonize muscarinic acetylcholine M receptors, regulate retinal and scleral function, improve choroidal blood supply, inhibit axial elongation, and alleviate myopia progression. Delaying the progression of myopia in children aged 6 to 12 with equivalent spherical diopter ranging from -0.50D to -4.00D (astigmatism ≤ 1.50D, anisometropia ≤ 1.50D) is the proposed indication for this drug.

It is reported that in August 2024, the Phase II/III clinical trial of the eye drops (HR19034-301) reached the primary research endpoint set by the protocol. As of now, the HR19034 eye drops related project has invested approximately 50.32 million yuan in research and development expenses.

The announcement shows that similar products that have been approved for market include atropine sulfate eye drops from Aspen Australia, Entod India, and Tatsunomiya Japan, while the only approval in China is held by Xingqi Eye Medicine.

On March 11, 2024, Xingqi Eye Medicine took the lead in obtaining the first approval for atropine sulfate eye drops, and was approved for clinical use to delay the progression of myopia in children aged 6 to 12 with a spherical refractive error of -1.00D to -4.00D (astigmatism ≤ 1.50D, anisometropia ≤ 1.50D). Due to the approval of atropine sulfate eye drops, Xingqi Eye Medicine's stock price surged 12.88% as of the close on the same day.

But the competition in the field of atropine sulfate eye drops is also fierce. On January 2nd, Zhaoke Ophthalmology announced that the National Medical Products Administration has accepted a simplified new drug application for NVK002 (low-dose atropine 0.01%), one of the company's core products used to treat deepening myopia in children.

In addition, according to data from Moen Pharmaceutical, there are currently over 40 clinical trials involving this drug in China. Among them, atropine sulfate eye drops under several pharmaceutical companies, such as Sepsis (603168. SH), Borui Pharmaceutical (688166. SH), Okonvivision Bio-B (01477. HK), and Qilu Pharmaceutical, have all entered phase 3 clinical trials, with indications including delaying or treating childhood myopia, intermittent exotropia combined with myopia, etc.