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A new drug for the treatment of brain tumors manufactured by Grand Pharmaceutical Group (0512) has been given the green light by Chinese regulators.

The investigational new drug application of TLX101, a radionuclide-drug conjugate of the group for the treatment of glioblastoma was accepted by the National Medical Products Administration of the People's Republic of China recently.

Glioblastoma is the second most common brain tumor after meningioma, with an annual incidence of 3.2/100,000 and a five-year survival rate of only 5 percent.

Currently, existing treatment can only delay the progression of the tumor but cannot avoid its recurrence and TLX101 is expected to be a pioneering approach in the field of glioblastoma treatment.

Grand Pharma said the drug signals important progress in the field of nuclear medicine tumor diagnosis and treatment.

The group's core product, YiGanTai anti-tumor injections, was granted approval for commercialization in January 2022.

Meanwhile, Lepu Biopharma (2157) has obtained the latest data from phase 1a dose-escalation trials of CMG901, a drug for advanced solid tumors co-developed with Keymed Biosciences.

The trial evaluated the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumor activity of CMG901 in patients with advanced solid tumors. CMG901 has been approved for clinical trials in both China and the US.

Grand Pharma’s TLX101 targets glioblastomas. BLOOMBERG

Brain cancer drug gets green light