On April 22, Hong Kong stock innovative pharmaceutical company Yunding Xinyao (01952. HK) announced that the company has obtained approval from the Hong Kong Stock Exchange to remove the "B" mark from its stock code. This marks another milestone in the company's development history, as Yunding Xinyao has reached higher standards in terms of market value and revenue, and its commercialization capabilities have been further recognized.

Since its listing on the Hong Kong Stock Exchange in October 2020, Yunding Xinyao has been focusing on the high-value "blue ocean" field under the "dual wheel drive" strategy of "authorized introduction" and "independent research and development". At the same time, it is committed to developing innovative therapies that are pioneering or best in class. The company has formed a strong and synergistic platform in the fields of kidney disease, infectious diseases and autoimmune disease, and three commercial products have achieved rapid growth in performance.

According to the 2024 annual performance report of Yunding Xinyao, the company's total revenue for the year reached 706.7 million yuan, a significant increase of 461%, exceeding the established target of 700 million yuan and achieving annual commercial profitability for the first time.

Among them, the sales of the world's first IgA nephropathy treatment drug, Nivolumab, reached RMB 353.4 million, a year-on-year increase of 1581%. It has been included in the national medical insurance drug catalog; The world's first tetracycline based antibacterial drug, Yijia, achieved a revenue of 352.8 million yuan, a year-on-year increase of 256%; VELSIPITY, the best drug of its kind in the field of autoimmune diseases, has been approved for marketing in Macau and Singapore, China, and has successfully entered the Guangdong Hong Kong Macao Greater Bay Area through the "Hong Kong Macao Drug and Device Connect" policy. Its new drug marketing application was officially accepted in December 2024 in mainland China and Hong Kong, China.

In terms of innovation pipeline, Yunding Xinyao's new generation BTK inhibitor EVER001, which has global rights, has shown positive clinical data and the global development process is steadily advancing. As a potential best in class product, EVER001 has great potential in primary membranous nephropathy and other autoimmune nephropathy, and is expected to become another heavyweight pipeline for Yunding Xinyao in the field of kidney disease.

Meanwhile, Yunding Xinyao utilizes its AI driven mRNA technology platform to develop tumor and other therapeutic mRNA drugs through multiple pathways. At present, Yunding Xinyao has formed three core pipelines: the self-developed personalized tumor therapeutic vaccine EVM16 has entered the clinical stage and completed the first patient administration in March this year; The clinical trial application for the universal spot tumor therapeutic vaccine EVM14 has been approved by the US FDA, becoming the company's first self-developed mRNA tumor therapeutic vaccine to enter the global clinical stage; The autologous CAR-T project will also complete its first preclinical candidate drug screening this year.

In addition, Yunding Xinyao has its own commercial scale production base located in Jiashan, Zhejiang, which meets the global Good Manufacturing Practice (GMP) standards and provides solid support for the research and development, production, and commercialization of mRNA technology platforms. In March of this year, the company announced the launch of the production and construction project of Yiqumod located in Jiashan factory, providing support for the localization production of Yiqumod.

In its latest research report, China International Capital Corporation (CICC) pointed out that Yunding Xinyao's business focus is precisely on the fields of kidney disease treatment and mRNA tumor vaccines, and it is expected that the growth of its core product portfolio will continue to exceed market expectations. Considering the improvement of the company's profitability and the reflection of product valuation, CICC has raised its target price to HKD 70 and maintained its "outperform the industry" rating.

In the industry's view, removing the "B" mark is an important indicator of the development of an 18A biotechnology company, based on comprehensive considerations of its product research and development pipeline, commercialization capabilities, and other aspects. Yunding Xinyao's "B" removal marks the recognition of its financial performance and commercialization capabilities by the capital market, which helps attract institutional investors and enhance secondary market liquidity. The company relies on revenue growth, enhanced profitability, and commercial platforms to solidify its position in the core treatment field and promote the transformation of AI+mRNA technology. As high potential products enter the harvest period, their long-term growth and globalization potential will be accelerated, and their strategic positioning as a leading comprehensive biopharmaceutical company in Asia will become increasingly clear.