China’s drug developers Innovent Biologics Inc (OTCMKTS: IVBXF) and Beijing Aosaikang Pharmaceutical Co Ltd (ASK Pharm) (SHE: 002755) have secured a milestone approval from national regulators for their orally administered lung cancer therapeutic.
Innovent revealed Thursday that the nation’s National Medical Products Administration has provided the companies with a New Drug Application (NDA). “Limertinib” targets epidermal growth factor receptor (EGFR) T790M-mutated non-small cell lung cancer (NSCLC) — a particular variation of the most common type of the respiratory disease that impacts approximately 40 per cent of patients in Asia.
The approval follows successful drug trial results demonstrating a favourable overall response rate of 68.8 per cent and a disease control rate of 98.4 per cent. This essentially means that the cancer receded or got smaller in nearly 70 per cent of participants who took the drug and that nearly all of their tumours either shrunk or did not spread any further.
“Patients treated with limertinib showed a reduced risk of central nervous system progression or death,” principal study investigator, Shi Yuankai, said in a news release. “This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China.”
Innovent achieves another milestone
This isn’t the only significant development that Innovent has had this week. The biotech operator announced Thursday that it had obtained Breakthrough Therapy Designation from China’s Center for Drug Evaluation for its pancreatic cancer treatment drug “IBI343.”
On another note, Innovent is currently developing a treatment for small cell lung cancer, the less common and deadlier variation, in partnership with the Swiss major Roche Holdings AG Basel ADR Common Stock (OTCMKTS: RHHBY). They revealed their new collaboration two weeks ago. Innovent now has 14 products in its portfolio.
ASK Pharm focuses on developing oncology drugs like these, antibiotics and other therapeutics.
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Innovent stops by J.P. Morgan’s prominent healthcare conference
The biopharma operator gave a presentation on its recent developments at the renowned American bank’s prestigious healthcare networking event. The drug being developed with Roche was one of the key topics.
“Looking ahead to 2025, the company plans to submit NDAs or conduct ongoing registrational trials for seven drugs while initiating pivotal or registrational trials for seven innovative pipeline candidates, pending proof of concept results,” Innovent explained.
The 43rd annual J.P. Morgan Healthcare Conference concluded yesterday. It is estimated to have generated US$92 million for the city of San Francisco this year due to the large number of attendees and their expenditures while visiting. Over 7,500 people representing companies and investment firms from around the globe were present.
rowan@mugglehead.com
