On March 24, Grand Pharmaceutical Group Limited (hereinafter referred to as " Grand Pharmaceutical "), a Hong Kong-listed company, announced on its official WeChat account that its strategic partner in the field of radiopharmaceuticals, Telix Pharmaceuticals Limited (hereinafter referred to as "Telix"), recently announced a major positive development. The first part (safety and dosimetry-guided) of the international multicenter Phase III clinical trial (ProstACT Global) of TLX591-Tx, a candidate drug for the treatment of prostate cancer labeled with lutetium, has successfully met its primary objective, demonstrating the safety and tolerability of the product, and no new adverse reactions were observed.

It is understood that TLX591-Tx is the world's first lutetium-labeled therapeutic rADC. Its targeting and pharmacological properties are significantly different from existing marketed prostate-specific membrane antigen (PSMA)-targeting small peptide molecules, aiming to achieve high internalization rate, long retention time and high selectivity for PSMA.

The progress made in ProstACT Global is a randomized, open-label, international, multicenter phase III clinical trial designed to evaluate TLX591-Tx in combination with standard therapy (abiraterone, enzalutamide, or docetaxel) versus standard therapy alone in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is one of the most common types of cancer among men in my country, and its incidence and mortality rates are showing a significant upward trend due to factors such as the aging population. According to Frost & Sullivan data, the prostate cancer drug market is projected to grow to nearly 50.6 billion yuan by 2030, while the global market size will reach 37.6 billion US dollars during the same period.

Targeting this blue ocean market with enormous potential, Grand Pharma has proactively deployed several innovative products, including the globally innovative RDC product portfolio TLX591-CDx and TLX591 for prostate cancer diagnosis and treatment, as well as the innovative product Youhu for early prostate cancer detection. It is reported that TLX591-CDx has maintained rapid sales growth since its overseas launch, achieving revenue exceeding US$600 million in 2025, representing a year-on-year increase of over 20%. Currently, the New Drug Application (NDA) for this product in China has been accepted.

As one of the world's leading companies in the field of radiopharmaceutical anti-tumor diagnosis and treatment, Grand Pharmaceutical has achieved a comprehensive layout in the radiopharmaceutical sector, encompassing R&D, production, distribution, and sales. Based on its core R&D bases in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering more than 50 countries and regions worldwide, the company has achieved a global layout of the radiopharmaceutical industry chain.

In terms of products, based on the integrated treatment concept of tumor diagnosis and treatment, the company has 16 innovative products in reserve during the research and registration stage, covering 5 radionuclides including 68Ga, 177Lu, 131I, 90Y and 89Zr, covering 7 types of cancer including liver cancer, prostate cancer and brain cancer; in the early research and development stage, the company mainly focuses on RDC drugs, with more than 10 products in reserve, covering both diagnostic and therapeutic radionuclide drugs.

With the continued expansion of the global radiopharmaceutical market, Grand Pharmaceutical is expected to leverage its first-mover advantage and full-industry chain capabilities to further implement its "Go Global" development strategy and expand its share in the global radiopharmaceutical market.

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