The company announced that its globally innovative radionuclide conjugate drug (RDC) ITM-11 for the treatment of gastrointestinal and pancreatic neuroendocrine tumors has recently been approved by the National Drug Administration to conduct phase III clinical research (COMPOSE study).
According to the Zhitong Finance App, soon after Yuanda Pharmaceutical (00512), an innovative Hong Kong stock pharmaceutical company, published its impressive 2023 earnings report, the company's nuclear drug anti-tumor diagnosis and treatment sector once again received good news. On the evening of March 24, the company announced that its innovative global radionuclide conjugate drug (RDC) ITM-11 for the treatment of gastrointestinal and pancreatic neuroendocrine tumors has recently been approved by the National Drug Administration to conduct phase III clinical research (COMPOSE study).
It is worth noting that the COMPOSE study is an international multi-center phase III clinical study. On the one hand, the addition of Chinese clinical trials will greatly promote ITM-11 registration and research in China, and on the other hand, it will further enhance the degree of internationalization of Yuanda Pharmaceutical's clinical development work in the field of nuclear drug anti-tumor diagnosis and treatment. At present, Yuanda Pharmaceutical has become the company with the largest reserves of innovative diagnostic and therapeutic RDC drugs entering phase III clinical research in China. It is also one of the innovative pharmaceutical companies with the richest product pipeline and integrated layout of diagnosis and treatment in the global nuclear drug anti-tumor field.
ITM-11 R&D process is accelerated, product advantages are remarkable, and market prospects are broad
ITM-11 is an innovative RDC drug that targets and kills gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs) based on radionuclide conjugation technology. This product will be carrier-free177Lu is coupled to somatostatin analogs and targets tumor cells by binding to somatostatin receptors (SSTR) expressed at high levels on the GEP-nets surface. With currently commonly used carriers177Compared to Lu nuclide products, carrier-free177Lu has higher specific activity and purity, and the production process produces fewer impurities with a long half-life, and less radioactive contamination. ITM-11 has been certified as an orphan drug by the US FDA and the European Medicines Agency (EMA).
The ITM-11 approved COMPOSE study is a prospective, randomized, controlled, open-label, international multi-center phase III clinical study to evaluate the efficacy, safety, and patient-reported outcomes of this product compared to the best standard treatment in highly differentiated aggressive grade 2 and 3 patients with somatostatin receptor-positive (SSTR+) GEP-nets. The COMPOSE study plans to enroll at least 202 patients in 11 countries around the world, including China, the United States, the United Kingdom, France, Germany, and Australia.
Neuroendocrine tumors (NETs) are rare tumors that originate from diffuse endocrine system cells and can occur in many organs and tissues throughout the body. Among them, the digestive system is the most common. Some studies have shown a marked increase in the incidence of GEP-nets in recent years, accounting for about 70% of all neuroendocrine tumors. According to Frost & Sullivan data, there were 71,300 new confirmed cases of GEP-nets in China in 2020, and the incidence rate is increasing year by year. Due to hidden onset, atypical symptoms, and high heterogeneity, the diagnosis and treatment of GEP-nets is very difficult and complicated.
The “CSCO Neuroendocrine Tumor Diagnosis and Treatment Guidelines 2021” suggests that 177Lu-based peptide receptor radionuclide treatment is superior to high-dose octreotide (somatostatin analogue) currently used in clinical frontline medicine in terms of indicators such as progression-free survival time (PFS) and objective response rate (ORR), and can bring obvious patient benefits. Using a carrier-free one177Lu's ITM-11 has considerable application space, and is expected to break through the difficult situation of GEP-nets treatment in China in the future. In addition, ITM-11 can also be used with TocScan, another RDC product used by Yuanda Pharmaceutical to diagnose GEP-netsThe formation of a product portfolio to integrate diagnosis and treatment of GEP-nets is expected to provide a new diagnosis and treatment plan for GEP-nets patients in China and further improve the clinical efficacy and quality of life of patients.
Forward-looking layout of the RDC circuit to stabilize the world's leading position in innovative nuclear drugs
Medraysintell, a market intelligence agency focused on radiation therapy and nuclear medicine, predicts that the global nuclear drug market will reach approximately US$30 billion by 2030. Thanks to their special mechanism of action, RDC drugs can achieve high-precision diagnosis and have advantages such as resistance to drugs in the treatment of diseases, so RDC is currently considered one of the most promising development directions in the field of targeted nuclear drug therapy. With giants such as Roche, Eli Lilly, Novartis, Bayer, and BMS betting on the RDC circuit, it will undoubtedly push RDC into a pharmaceutical investment trend in 2024.
In terms of products, Telix's TLx591-cdx (Illuccix), which is used to diagnose prostate cancer, achieved an increase in sales revenue exceeding expectations. Its revenue for the full year of 2023 exceeded 503 million Australian dollars (about 2.4 billion yuan), an increase of nearly 214% over the previous year; Novartis lutathera for treating GEP-nets (177(Lu-labeled somatostatin analogues) sales revenue has also increased rapidly. The product's global sales revenue reached about US$605 million in 2023, and the cumulative revenue since marketing has already exceeded US$2.6 billion. In comparison, ITM-11 is based on its significant clinical advantages over similar products, and the market prospects are very promising.
In fact, Yuanda Pharmaceutical already laid out the nuclear drug field and RDC circuit as early as 2018. According to the announcement, the company's nuclear drug anti-tumor diagnosis and treatment division has now achieved a comprehensive layout of R&D, production, sales, regulatory qualifications, etc., established a complete industrial chain, and built an international first-class interventional oncology research and development platform and RDC drug development platform through cooperation with Sirtex, Telix and ITM.
In terms of products, Yuanda Pharmaceutical focuses on the integrated treatment concept of cancer diagnosis and treatment. Currently, it has prepared 14 innovative products, 9 of which are RDC innovative drugs, covering68Ga,177Lu,131I,90Y,89Zr,99Six types of radionuclides, including MTC, cover 7 types of cancer, including liver cancer, prostate cancer, brain cancer, etc.; in terms of product types, it covers the diagnosis and treatment of two types of nuclide drugs, providing patients with a world-leading anti-tumor solution with multiple treatment options, multiple methods, and integrated diagnosis and treatment.
At present, the company has 4 innovative RDC drugs approved for clinical research in China, 3 of which have entered phase III clinical phase, including TLx591-cdx, a product for diagnosing prostate cancer, TLx250-cdx for diagnosing clear cell renal cell carcinoma, and ITM-11 for treating GEP-nets. Yuanda Pharmaceutical has become the company with the largest reserves of innovative RDC drugs for diagnosis and treatment that have entered phase III clinical trials in China. It is also one of the innovative pharmaceutical companies with the richest product pipeline and integrated diagnosis and treatment layout in the global nuclear drug anti-tumor field.
According to Yuanda Pharmaceutical's 2023 financial report, the company recorded revenue of about HK$10.53 billion in 2023, an increase of 15.8% year-on-year, excluding exchange rate effects. Among them, the anti-tumor segment of nuclear drugs achieved revenue of about HK$220 million, and the annual revenue growth rate of core products was nearly 300%. The company's forward-looking layout and leading edge in the R&D process in the field of nuclear medicine have gradually been realized, and its pipeline layout with integrated diagnosis and treatment is also expected to promote the rapid commercialization of products in the future.
Yuanda Pharmaceutical said that the company is currently promoting the construction of a domestic Class A certified nuclide production platform in an orderly manner. In the future, the company will continue to strengthen R&D and investment in the nuclear drug anti-tumor diagnosis and treatment sector, enrich and improve the product pipeline and industrial layout, form a nuclear drug anti-tumor diagnosis and treatment product cluster with Yi Gantai as the core, and continue to consolidate its position as a leading enterprise in the field of nuclear drug anti-tumor diagnosis and treatment in the world.