May 15, 2025
Source: drugdu
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On the evening of May 12th, Yuanda Pharmaceutical once again disclosed the new progress of a globally innovative radionuclide coupled drug TLX591 CDx under research. The Phase III clinical trial of this drug in China has been completed with all patients enrolled for administration, and it is planned to submit a new drug application for market launch in China this year. This is the third major innovative research and development progress announced by Yuanda Pharmaceutical since May 6th. From May 7th to May 12th, the stock price of Yuanda Pharmaceutical rose strongly and reached a historical high of HKD 8.95 per share on May 12th. On May 13th, the stock price slightly fell, and as of the close, the stock price was HKD 8.29 per share, with a cumulative increase of 38.4% from May 7th to May 13th.
This year, with the recovery of pharmaceutical stocks, the position of innovative drugs: BK1106 1105.92-0.38%+self selection is becoming increasingly evident, and market signals are gradually emerging. On May 12th, Open Source Securities released a research report stating that the industrial adjustment is nearing its end, and the pharmaceutical index has already stabilized and rebounded. The current industrial innovation and development are being vigorously promoted, policies are stable and improving, unmet clinical needs are rapidly increasing under the background of aging, and the innovation capabilities of enterprises are constantly improving. The innovative drug sector is expected to usher in new opportunities.
Three innovative drugs have made new progress
Yuanda Pharmaceutical is one of only four pharmaceutical companies in the world that has achieved commercialization of innovative nuclear drugs. The announcement disclosed on May 12th shows that TLX591 CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) based on radionuclide small molecule coupling technology, suitable for the diagnosis of metastatic and recurrent prostate cancer.
This time, we completed a single arm, open label phase III clinical study. In more than 100 patients with biochemical relapse after radical prostatectomy and/or radical radiotherapy for prostate cancer, we used TLX591 CDx and performed positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) tests to evaluate the diagnostic effectiveness of the product, as well as the safety and tolerance of the product in the Chinese population.
Yuanda Pharmaceutical disclosed that the progress of the drug's global registration and listing is smooth, and it has been approved for listing in Australia, the United States, Canada, Brazil, the United Kingdom, and multiple European countries. It achieved nearly $517 million in sales in 2024 and nearly $151 million in sales in the first quarter of this year, a year-on-year increase of nearly 35%.
On May 6-7, Yuanda Pharmaceutical also disclosed new developments in the research and development of two other products: its globally innovative radionuclide conjugate drug (RDC) product TLX591 for the treatment of prostate cancer has been accepted by the National Medical Products Administration for its application to join the international multicenter phase III clinical trial; The second phase clinical trial of its globally innovative product STC3141 in China has successfully reached the clinical endpoint, and the clinical research progress is at the forefront of the global sepsis research field.
Nuclear drug anti-tumor diagnosis and treatment is one of the strategic areas that Yuanda Pharmaceutical focuses on. According to the disclosure of Yuanda Pharmaceutical, the company has reserved 15 innovative products in the research and development registration stage of the field around the treatment concept of integrated diagnosis and treatment of tumors, covering 5 types of radioactive isotopes and 7 types of cancer including liver cancer, prostate cancer, kidney cancer, brain cancer, etc. As of now, four RDC innovative drugs have been approved for registered clinical trials, of which three have entered the third phase of clinical trials.
According to the 2024 annual report data of Yuanda Pharmaceutical, the core product of the nuclear medicine sector, Yigantai Yttrium [90Y] Microsphere Injection, has become the core engine of performance growth. This product contributed nearly HKD 500 million in revenue in 2024, with a year-on-year growth rate of over 140%. It has achieved a significant increase in sales revenue for two consecutive years, both exceeding 100% year-on-year, and has driven the nuclear medicine sector to achieve a significant increase in revenue of nearly 177%. According to a research report by Western Securities, Far East Pharmaceutical's nuclear drug output exceeded expectations and its performance turned upward.
Innovative pharmaceutical field may usher in new opportunities
Yuanda Pharmaceutical has made significant progress in the research and development of three innovative drugs, triggering a sharp rise in stock prices and reflecting the increasingly prominent position of innovative drugs.
Chinese pharmaceutical stocks have been continuously adjusting for over three years, and at the beginning of this year, the pharmaceutical sector, especially in the field of innovative drugs, experienced a strong recovery. As of the close on May 13th, the cumulative range growth rate of the Hong Kong stock innovation drug index this year is 22.67%. Especially from January 17th to April 1st, the cumulative growth rate reached 42.6%, and on April 1st, it surged to the highest point of 1000.95 points this year.
On May 12th, Open Source Securities released a mid year investment strategy recommendation for the pharmaceutical industry in 2025, focusing on pioneering new drugs. Affected by the overall business pressure of the industry, the pharmaceutical index has fluctuated downward since 2021, and the industrial adjustment is nearing its end. Since the fourth quarter of 2024, the pharmaceutical index has gradually stabilized at the bottom. At present, industrial innovation and development are being vigorously promoted, and it is clearly proposed to optimize centralized drug procurement, with stable and positive pharmaceutical policies; The long-term industry trends, such as the rapid growth of unmet clinical needs and the continuous improvement of enterprise innovation capabilities in the context of aging, have not changed. With the new cycle driven by innovative drugs in the pharmaceutical sector, the normalization of medical compliance, and the gradual recovery of consumer healthcare, the pharmaceutical sector is expected to return to stable growth, and the index is also expected to rise.
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