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Youshiying (OT-401), Company's Core Product, Commercialized ahead of Schedule
Speed up the Launch of New Products |
HONG KONG, Mar 30, 2023 - (ACN Newswire) - Ocumension Therapeutics ("Ocumension" or the "Company", together with its subsidiaries, collectively the "Group", stock code: 1477), a leading China ophthalmic pharmaceutical platform company, announced its annual results for the year ended 31 December 2022 today.
2022 was a year full of challenges and opportunities which the Company survived the ups and downs of the COVID-19. Courageous without hesitations is always the mission Ocumension Therapeutics committed to stick with. Given that, the Group achieved remarkable results during the year. It was attributable to the successful commercialization of multiple companies' core products which boosted the sale, plus the increase of revenue generated from the sales of ophthalmic products. During the year, operating revenue surged 183.1% to RMB159.0 million, as compared to RMB56.1 million in 2021. Consolidated gross profit margins was approximately 64.7%, total R&D expenses for the year amounted to RMB184.3 million, an increase of 9.0% as compared to 2021. Loss for the year attributable to the owners of the company was RMB402.6 million, mainly because no one-time gain was generated from the transaction with third parties, and the increase in share-based payments which the Group has further granted options, awards and RSUs under the share incentive schemes to our employees and consultant during the Reporting Period.
The Group continued to accelerate the penetration of the drugs in hospitals in the PRC ophthalmology market, achieving a coverage of 8,171 hospitals nationwide, 1,384 of which are Grade III hospitals, and a commercialization team of 191 people, thereby having completed the national commercialize network coverage. During the Reporting Period, the sales of Ou Qin and Emadine increased by 64% and 199%, respectively, as compared to the year ended December 31, 2021.
The Group continued to promote research and development progress during the year, the NDA for the Company's Core Product, Youshiying (OT-401), was approved by the NMPA in June 2022 for the treatment of chronic NIU-PS and commercialization in the PRC, ahead of the expected schedule. Youshiying was subsequently launched officially in December 2022 and completed the first patient injection, this is the first drug approved in China fully based on real-world study data and overseas clinical data, marked a milestone achievement in the history of drug registration in China and demonstrated the Company's research and development capabilities. At the same time, which in turn is also expected to boost the sales performance of the Company in 2023.
In addition, the phase III clinical trial of ZERVIATE (OT-1001), a potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has achieved its primary clinical endpoint and received positive results. The Company received approval from CDE for the phase III clinical trial of ILUVIEN (OT-703) for the treatment of diabetic macular edema (DME), having increased the total number of drug candidates in the stage of phase III clinical trial to six, giving the Company a significant lead over other competitors. OT-202 being one of the in-house developed new chemical entity (NCE) ophthalmic drugs with whole new targets and the fastest clinical progress in China for many years has drawn extensive attention from the medical community. As of now, the Company has successfully completed the phase I clinical trial of OT-202, and has initiated its phase II clinical trial on a researcher conference. The smooth progression of the project OT-202 served as concrete proof of the Company's solid innovation and research and development capabilities.
The research and development of the other pipeline products of the Company has also been continuously advancing in 2022. The completion of patients enrollment in China for the global phase III clinical trial of OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia, signified the achievement of the milestone event of OT-101, which is expected to greatly accelerate the R&D and registration process of the such drug candidate, enabling patients in China suffering from myopia to have the opportunities to receive timely treatment.
The Company has established a comprehensive marketing and promotion system within the year. With the support of the system, Ocumension has met its aggregated sales goal of revenue of over RMB100 million in the fourth year since its inception. Meanwhile, the Company's sales efficiency has also further improved. Benefitting from its powerful commercialization network in the field of ophthalmic drugs, During the Reporting Period, the Company obtained the promotion right of all the ophthalmic pipeline products of Viatris in the hospitals nationwide in the PRC, further fortifying its leading position in the key fields such as glaucoma and antiallergy in the PRC, as well as increasing the number of commercialized pipeline products of the Company to 14.
Besides, our Suzhou manufacture site started pilot-scale and process validation batch production in May 2022. With the highly automated production lines, the production standard of our Suzhou manufacture site was able to reach the world-class manufacturing level and thus to ensure the quality and production efficiency of the products of the Company. The inauguration and start of operation of our Suzhou Xiaxiang manufacture site have not only firmly assured the Company's further improvement in sales, cost reduction, stable supply and enhanced profitability, but also demonstrated the manufacturing capabilities of the Company, lay a solid foundation for potential opportunities for international cooperation on the production of drug products in the future.
Looking forward to 2023, the Company will further advance and accelerate the process for registration and commercialization of the drug candidates under research and development, introduce more in-house developed products into clinical trial stage and maintain a wholesome product portfolio, so as to sustain its leadership among the peers in terms of the product pipeline. Pivoting the launch of the Core Product, Youshiying, the Company's commercialization team will further widen the scope and deepen the level of its promotion in the academic aspect, and strive to maintain the Company's exponential growth in sales.
In terms of research and development, at least two new products of the Company will enter the registration stage in 2023, keeping the pace of the continuous launch of new products. In terms of manufacture and production, our Suzhou Xiaxiang manufacture site will achieve commercialized mass production to ensure the stability of supply and the quality of products. At the same time, as the team stability and cohesion were finally achieved, be committed to building a unique corporate culture catering to Ocumension to safeguard our sustainable development and growth in the next stage in 2023.
Mr. Ye LIU, CEO and Executive Director of Ocumension, said: "As a young biopharma, Ocumension is marching into the fifth year since its inception. Leveraging the ameliorative market trend and favorable business environment in 2023, the Company will continue to grow at an exceptional pace as a pioneer, so as to repay the Shareholders' trust in and support to the Company. "
About Ocumension Therapeutics
Ocumension Therapeutics is a Chinese ophthalmology platform company dedicated to identifying, developing and commercializing pioneering or best-in-class ophthalmic therapies. The company's vision is to provide world-class drug solutions to meet the huge demand for ophthalmology treatments in China. We believe that our ophthalmology platform with its obvious first-mover advantage will give us a leading position in the ophthalmology industry in China. Up to now, the company has 24 kinds of drug assets in front of the eye and back of the eye, and has established a complete ophthalmic drug product line, six of which have entered phase III clinical trials in China. On July 10, 2020, Ocumension was listed on the main board of the Stock Exchange of Hong Kong Limited (stock code: 01477).
More information about Ocumension Therapeutics: https://www.ocumension.com/
Topic: Press release summary
Source: Ocumension Therapeutics
Sectors: BioTech, Healthcare & Pharm
https://www.acnnewswire.com
From the Asia Corporate News Network
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