China’s Regulatory Body Accepts Application for First Selective Internal Radiation Therapy for HCC
In 2018 alone, 841,000 new hepatocellular carcinoma cases occurred worldwide, and China accounted for 47.6% of them. As per a 2015 statistic, metastasis of colorectal cancer to the liver contributed 188,000 cases as the number of new cases of colorectal cancer shot up to 376,300 in China. Due to the ineffectiveness of current treatments, Chinese patients are left with fewer options than those in developed countries.
On November 26th, China’s National Medical Products Administration (NMPA) announced the acceptance of a New Drug Application (NDA) of a liver cancer medication. Based upon clinical studies conducted overseas, Sirtex Medical and China Grand Pharmaceuticals’ (CGP) SIR-Spheres Y-90 resin microspheres were filed for approval. Earlier in August, Sirtex and CGP received the “Approval Notice of Drug Clinical Trial” from the NMPA, which permits Y-90’s clinical trials to be conducted in China. Sirtex anticipates commercial approval of its therapy with the allowance to treat unresectable metastatic colorectal cancer (mCRC) in combination with fluorouridine adjuvant chemotherapy in the fourth quarter of 2021.
Kevin R. Smith, Chief Executive Officer of Sirtex, said, “We celebrate this achievement in our journey to provide a valuable treatment option to people with liver tumors from mCRC in China . . . [and] express deep thanks to the members of CGP, Sirtex China and our Global Regulatory, Quality Assurance, Operations, and Medical teams as they navigated the regulatory process and secured acceptance of the NDA by the NMPA.”
SIR-Spheres Y-90 Resin Microspheres
Y-90 resin microsphere, a small, novel particle, is the only radioactive microspheres approved by the FDA worldwide. It directly delivers radiation to the affected liver cells in order to achieve maximum disease control through optimal tumor coverage. Besides this, with the microspheres living preferentially in the microvasculature of the tumor, maximizing tumoricidal effects and minimizing effects on unaffected liver parenchyma were important factors when designing the Y-90 particle.
Significant clinical research on Y-90 resin microsphere has been conducted in Europe, Hong Kong, the US, and Taiwan, and the results demonstrated a significant increase in response rate, reduced tumor burden, and achieved decent tumor-shrinking for patients to be able to remove the tumor surgically. The therapy also extends the progression-free survival and the time needed to wait for transplantation.
CGP has adopted the strategy of “global expansion and dual-cycle operation,” as they believe anti-tumor radiopharmaceuticals and precision interventional therapy would be one of the major future focuses in the pharmaceutical industry. CGP’s decision to acquire Sirtex gives it a 49% equity of interests of Sirtex and offers an opportunity for CGP to fortify in the field of interventional oncology.
“Looking ahead, the Group will continue to expand its strategic planning in the anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy,” a board member of CGP commented.
“Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including US-based OncoSec, Australia based Sirtex and Telix, the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and precision interventional platform integrating diagnostics and treatment”.
By Judy Ya-Hsuan Lin
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