NO.1 Two biosimilars of pertuzumab approved for market launch

On December 23rd, the official website of the State Administration for Market Regulation showed that two types of pertuzumab injections were approved for market, one from Qilu Pharmaceutical and the other from Zhengda Tianqing. Patuximab was originally developed by Roche and was first approved for market by the FDA in 2012. It was first approved for market in China in 2018. Currently, multiple indications have been approved worldwide.

Comment: Since its approval, the pertuzumab market has performed exceptionally well, with global sales of $4.2 billion in 2023. As a biosimilar drug, it is expected to occupy a certain market share in the original drug market. But currently, there are 7 domestic companies developing drugs similar to pertuzumab, and competition may intensify in the future.

NO.2 Kangnuosipuqibai monoclonal antibody second indication approved

On December 23rd, Konya announced that its independently developed Class 1 new drug, Kangyueda (Sipuximab Injection), has been approved for market by the National Medical Products Administration for the treatment of chronic sinusitis with nasal polyps.

Comment: Some patients with chronic sinusitis still experience persistent symptoms or polyp recurrence after medication and surgical treatment. As the first approved biologic for the treatment of chronic sinusitis with nasal polyps in China, Sipuximab provides patients with a new treatment option.

Roche's dual anti cancer therapy, Motuzumab, has been approved for marketing

The latest announcement on the official website of the China National Medical Products Administration (NMPA) shows that Roche's application for the marketing of pertuzumab injection has been approved. According to the priority review announcement of the Drug Evaluation Center (CDE) of the China National Medical Products Administration, this drug is used to treat adult patients with recurrent or refractory follicular lymphoma (FL) who have received at least two systemic treatments in the past.

Comment: This drug represents a new immunotherapy option that is chemotherapy free and readily available, and can be administered through intravenous therapy in outpatient settings. Follicular lymphoma is the most common type of indolent non Hodgkin lymphoma. Patients usually respond well to treatment, but it is often accompanied by recurrence. Every time a patient relapses, this disease usually becomes more difficult to treat, and early progression may be associated with poor long-term prognosis.

NO.4 Cornerstone Pharmaceuticals submits clinical trial application for PD-1/VEGF/CTLA-4 tertiary antibody in Australia

On December 23rd, Cornerstone Pharmaceuticals announced that its pipeline 2.0 heavyweight product CS2009 (PD-1/VEGF/CTLA-4 bispecific antibody) for the treatment of various solid tumors has submitted a clinical trial application in Australia. The study has also been registered and published on relevant websites.

Comment: Cornerstone Pharmaceuticals plans to launch CS2009's global multicenter, first human study in Australia in early 2025, and will gradually expand to China and the United States in the future. In the first half of this year, Cornerstone Pharmaceutical achieved profitability for the first time, with a net profit of nearly 16 million yuan. The company's R&D investment will continue to increase in the future.