Multinational Pharma Companies Accelerate China Expansion with Multiple New Drug Approvals in September

　　【Pharmaceutical Network Industry Dynamics】Based on China's ultra-large-scale market advantages and continuously optimized business environment, multinational pharmaceutical companies are increasingly investing in the Chinese market. As a result, an increasing number of imported new drugs and indications are also being constantly submitted for clinical trials and market approval in China.
 

On September 21, Novartis' Erenumab injection was approved for marketing in China. It requires only one injection per month for the prevention of migraine in adults. Erenumab is a fully human monoclonal antibody jointly developed by Amgen and Novartis that prevents migraines by blocking the activity of calcitonin gene-related peptide (CGRP). In May 2018, Erenumab received FDA approval, becoming the world’s first approved antibody drug targeting the CGRP receptor, and it was launched in the European Union in July 2018. According to the company's financial report, Erenumab generated revenue of $632 million in 2022.
 

On the same day, the CDE announced that AstraZeneca's new indication application for osimertinib has been accepted. Osimertinib is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastases. The product already has three indications approved in China: 1) For adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and who have confirmed EGFR T790M mutation positivity; 2) For first-line treatment of NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; 3) For adjuvant treatment in adult patients with EGFR-mutated NSCLC following tumor resection.
 

In addition to the aforementioned companies, this year, Pfizer, Takeda, Johnson & Johnson, Sanofi, Merck, Medtronic, and other large multinational pharmaceutical giants have been accelerating their expansion into the Chinese market and promoting the launch of their products in China. Notably, Eli Lilly and Company stands out, with multiple products approved just in September.
 

On September 18, CDE announced that the clinical trial application for Eli Lilly's FGFR3 inhibitor LOXO-435 tablets has been accepted. LOXO-435 tablets are an effective and highly subtype-selective FGFR3 inhibitor, active against FGFR3 gatekeeper resistance mutations. LOXO-435 can avoid dose-limiting toxicities caused by the inhibition of FGFR1 and FGFR2, namely hyperphosphatemia and other chronic intolerable adverse events.
 

On September 15, the website of the National Medical Products Administration (NMPA) showed that Eli Lilly's dulaglutide injection (brand name: Trulicity) had received approval for a new indication. Dulaglutide is a long-acting GLP-1 receptor agonist administered once weekly and can effectively reduce glycated hemoglobin (HbA1c).
 

On September 5, Eli Lilly and Company announced that Verzenio (abemaciclib tablets) had received approval from the National Medical Products Administration (NMPA) for an expanded indication, in combination with endocrine therapy (tamoxifen or aromatase inhibitors), as adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, high-risk early breast cancer. In December 2021, Verzenio (abemaciclib tablets) was approved for the early breast cancer indication, becoming the first CDK4 & 6 inhibitor in China approved for high-risk early breast cancer patients.
 

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