May Brings Exciting Advances in the New Drug Market with Multiple Product Milestones

　　【Pharmaceutical Station | Industry Dynamics] In May, the pharmaceutical industry saw a continuous stream of policy updates, rankings, and financing and M&A activities, while the new drug market was equally dynamic. Particularly in the Chinese market, the ongoing launch of new drug products has injected momentum into its robust growth and brought benefits to enhancing the competitiveness of pharmaceutical companies.
 

　　CSPC's Nintedanib for Pulmonary Fibrosis Accepted by CDE
 

Nintedanib, developed by Boehringer Ingelheim, is an oral anti-angiogenic targeted therapy. The recent submission for market approval of CSPC’s generic version will, on one hand, help patients gain timely access to high-quality, low-cost domestically produced drugs, thereby facilitating import substitution; on the other hand, given the current sluggish sales of nintedanib in China and the imminent adjustment of the National Reimbursement Drug List, if Boehringer Ingelheim fails to demonstrate a sincere commitment to price reductions—similar to those shown by Roche and Hengrui Medicine—to secure inclusion in the reimbursement list, its future sales performance is predictable.
 

　　Domestically Produced Long-Acting GLP-1 Preparations Approved for Market Launch
 

On May 6, 2019, Hansoh Pharmaceutical’s pegylated loxenatide received approval for market launch from the National Medical Products Administration (NMPA), becoming China’s first domestically produced long-acting GLP-1 agent to be marketed. According to Evaluate Pharma data and forecasts, the share of GLP-1 agonists among non-insulin antidiabetic drugs will rise significantly from 17% in 2014 to 35% in 2022, with sales exceeding $14 billion.
 

　FDA Approves First Drug for Rare Cardiomyopathy
 

On May 7, Pfizer announced that the FDA had approved Vyndaqel and Vyndamax for the treatment of wild-type or hereditary transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
 

　　FDA Approves Rapid Medical’s Temporary Aneurysm Embolization Assist Device
 

Rapid Medical, a company focused on developing next-generation neurovascular devices, announced that its Comaneci device has received approval from the U.S. Food and Drug Administration (FDA) as a Temporary Coil Embolization Assist Device.
 

　　China’s Independently Developed Long-Acting Diabetes Drug “Fulaimi” Approved for Market Launch
 

According to the website of the National Medical Products Administration, Fulaimi (pegylated loxenatide), independently developed by Hansoh Pharmaceutical, was submitted for Phase I clinical trials in 2007 and finally bore fruit after twelve years.
 

　　Three Major Generic Drugs from Chia Tai Tianqing Sequentially Approved
 

Following its May 20 announcement that the Class 6 generic version of gefitinib tablets had been approved for production, Chia Tai Tianqing also received approval in recent days for the production of its Class 4 generic apixaban tablets, which is deemed to have passed the consistency evaluation. This marks the third generic drug approved for production by Chia Tai Tianqing in May.
 

　　FDA Approves UCB’s New Epilepsy Drug Nayzilam
 

The U.S. FDA has approved Nayzilam (midazolam) nasal spray, a new antiepileptic drug, for the emergency treatment of intermittent, stereotyped episodes of frequent seizure activity (such as seizure clusters or acute repetitive seizures) in patients aged 12 years and older with epilepsy.
 

　　Fuan Pharmaceutical Group Ningbo Tianheng Pharmaceutical’s Tropisetron Hydrochloride Injection Receives Registration Approval
 

On May 21, Fu’an Pharmaceutical announced that its subsidiary, Fu’an Pharmaceutical Group Ningbo Tianheng Pharmaceutical Co., Ltd., had received a registration approval issued by the National Medical Products Administration (NMPA) on that day. Tropisetron Hydrochloride Injection belongs to antiemetic and antinausea medications and is classified as a Class B drug under China’s national drug classification system.
 

　　Denosumab and Recombinant Zoster Vaccine Approved for Market Launch
 

On May 22, the National Medical Products Administration (NMPA) issued an announcement stating that it had recently granted conditional approval for the import registration applications of Denosumab Injection and Herpes zoster vaccine (recombinant, adjuvanted).
 

　　CTTQ’s Apixaban Tablets Approved by China’s NMPA
 

According to the New Drug R&D Monitoring Database (CPM), Chia Tai Tianqing's apixaban tablets have been approved by the NMPA. Apixaban (brand name Eliquis) is an oral, selective factor Xa inhibitor.
 

　　FDA Gives Green Light to Novartis Gene Therapy Zolgensma
 

On May 24, Novartis announced that the U.S. FDA had given the green light to its gene therapy, Zolgensma. The company’s stock price surged by more than 4% on the same day. Zolgensma (onasemnogene abeparvovec-xioi) is a breakthrough gene replacement therapy for spinal muscular atrophy (SMA), a fatal disease.
 

　　Novocure’s Tumor Treating Fields Therapy System Receives FDA Approval
 

Biotechnology company Novocure (NASDAQ: NVCR) announced that its Tumor Treating Fields therapy system, NovoTTF-100L, has received FDA approval for the treatment of pleural mesothelioma.
 

　　Amgen’s Giant Cell Tumor Treatment Drug, Denosumab (Xgeva), Approved in China
 

Amgen China announced that XGEVA® (generic name: Denosumab Injection) has been approved by the National Medical Products Administration for the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, including in adult and skeletally mature adolescent patients (defined as having at least one mature long bone and body weight >45 kg).
 

　　Revlimid in Combination with Rituximab Approved by FDA
 

Celgene announced on May 28 that the U.S. FDA has approved the combination therapy of Revlimid (lenalidomide) and rituximab (R²) for adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).