On February 1, Zhaoke Ophthalmology suddenly dived in the afternoon and closed down 2809%，*2.150 yuan shares, market value 117.4 billion yuan. On the 2nd, Zhaoke Ophthalmology opened flat, and then killed all the way, and the lowest fell to 1850 yuan shares,**13.95%, as of 10:26, **1023%。
On the news side, Zhaoke ophthalmology partner Vyluma announced in June last year that the U.S. Food and Drug Administration (FDA) had accepted NVK002 (001% low-concentration atropine), which will approve this potential regimen for myopia in children. The U.S. FDA has designated the approval date for the NVK002 Prescription Drug User Payments Act (PDUFA) as:January 31, 2024。However, when the deadline came, NVK002 was not seen in the approved list published on the FDA's official website as of January 31. This big dive should be related to this.
The PDUFA date is a deadline by which the FDA must give a review opinion on the approved drug (approved, not approved, and the supplementary content will be considered for approval). There is currently no official FDA review decision, and it is unclear whether the review will be deferred or rejected outright.
Currently, low-concentration atropine (mainly in the form of 001% mainly) preparation products have been marketed in Singapore, Taiwan, Hong Kong, Japan and other regions with a high incidence of myopia, with an average annual cost of about 3,000-4,000 yuan. If the domestic product is officially launched, according to the annual cost of 1,500 yuan, the theoretical market space of atropine preparations is as high as 120 billion yuan.
Whether Zhaoke's NVK002 was approved by the FDA first, or Xingqi's atropine eye drops were approved firstcdeApproval, the market and industry are widely concerned. At the moment,Xingqi's atropine completed its pharmaceutical review on January 22 and showed its departure from the supplementary information task (Round 1) on January 29
Previously, Zhaoke and Xingqi often skyrocketed around the R&D and review progress of low-concentration atropine**. For example, on July 21, 2023, Xingqi Eye Medicine crashed rapidly in the afternoon, falling by more than 16% at one point.
It is reported thatnvk002As the first low-concentration atropine drug approved in the United States and even the world** for the progression of myopia in children. Previously, Zhaoke Ophthalmology achieved NVK002 through strategic cooperation with VylumaGreater China, South Korea, and select Southeast Asian countriesrights to clinical development and commercialization.
According to the announcement issued by Zhaoke Ophthalmology on October 28, 2022, in China, Zhaoke Ophthalmology has been conducting two phase III clinical trials in parallel, namely the two-year phase III clinical trial (CHAMP in China) and the one-year phase III bridging clinical trial (small CHAMP) in parallel. Patient enrollment was completed on July 21, 22 and July 28, respectively. Once NVK002 is approved by the FDA, Zhaoke Ophthalmology plans to file a new drug application in China based on the results of the mini-CHAMP study with Vyluma data from the Phase III CHAMP study.
It can be said that the vision of atropine is underpinningThe future of Zhaoke Ophthalmology。Zhaoke Ophthalmology, as a science and technology enterprise, is still losing money. According to the 2023 interim results, its realized revenue was RMB113040,000 yuan; R&D expenditure20.5 billion yuan, a loss of 23.4 billion yuan. In 2022, Zhaoke Ophthalmology recorded a total loss of about 40.7 billion yuan.
If atropine is not approved, Zhaoke Ophthalmology can only hope for a presbyopia drug pipeline.
On January 25, Zhaoke announced that the ND applications for Brimochol PF and Carbachol PF have been approved by the CDE. Brimochol PF is a fixed-dose combination of carbachol (choline) and brimonidine tartrate (a 2-receptor agonist). This research** causes the pupils to constrict, creating a "pinhole effect". On January 29, Zhaoke announced that it had entered into a relationship with a South Korean companykwangdongpHarmaceutical Enters into Distribution and ** Agreement for Brimochol PF Preservative-Free Topical Eye Drops.
Previously, in April 2023, Zhaoke announcedPositive topline results from the pivotal Phase 3 BRIO-I trial of Brimochol PF in presbyopia