Domestic Generic Drugs Gained Momentum in September with Multiple First-to-File Approvals, Accelerating Import Substitution

　　【Pharmaceutical Network Industry DynamicsIn September, which has just passed, the domestic generic drug market in China ushered in a "bumper season." The first generic qualifications for several blockbuster products were successively granted, involving pharmaceutical companies such as China Resources Double-Crane, Zhejiang Xianju Pharmaceutical Co., Ltd., Chia Tai Tianqing, and Lunan Pharmaceutical. These products cover various disease areas including pulmonary hypertension, prostate cancer, depression, and asthma. The approval of these products not only enriches patients' medication options but also demonstrates the strong capabilities of domestic pharmaceutical companies in generic drug research and development, quality control, and market layout.
 

On September 29, China Resources Double-Crane announced that its wholly-owned subsidiary, China Resources Double-Crane Limin Pharmaceutical (Jinan) Co., Ltd., had received the "Drug Registration Certificate" for Bosentan Dispersible Tablets issued by the National Medical Products Administration. As of the announcement date, the company's cumulative R&D investment in this drug amounted to 8.44 million RMB.
 

The indication for Bosentan Dispersible Tablets is pulmonary arterial hypertension (PAH), primarily used to improve pulmonary vascular resistance in specific patients. The original Bosentan was developed by Actelion, which was acquired by Johnson & Johnson for $30 billion in June 2017. In September 2017, its dispersible tablets were approved by the FDA, and in September 2019, the dispersible tablets were launched in China, becoming the first PAH drug for children approved in China. China Resources Double-Crane stated that the launch of this drug will enrich the company’s product portfolio and enhance market competitiveness.
 

On September 28, ApicHope announced that its wholly-owned subsidiary, ApicHope Pharmaceutical, had recently received the "Drug Registration Certificate" for Levocarnitine Oral Solution issued by the National Medical Products Administration. According to the approved instructions, the indication for Levocarnitine Oral Solution is primary systemic carnitine deficiency, with clinical manifestations including recurrent Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Related symptoms include hypotonia, muscular weakness, and developmental delay. The drug is also used for the short-term and long-term treatment of secondary carnitine deficiency caused by congenital metabolic disorders, with recommended dosage for infants, toddlers, and children included in the instructions.
 

On September 23, Norasooth® Bilastine Orodispersible Tablets (Specification: 10mg) from Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, were approved for marketing by the National Medical Products Administration and considered to have passed the generic drug quality and efficacy consistency evaluation.
 

This product is the first in China to be approved for marketing and is used for symptomatic treatment of urticaria in adults and adolescents (12 years and above). Data shows that bilastine is a second-generation non-sedating long-acting histamine antagonist, with selective peripheral H1 receptor antagonist affinity, no affinity for muscarinic receptors, no sedative effects, no cardiac toxicity, and no interaction with cytochrome P450 enzyme substrates. It has the characteristics of rapid onset, long duration, and high efficacy. The orally disintegrating tablets can rapidly disintegrate or dissolve in the mouth, have a good taste, are easy to swallow, and are non-irritating to the oral mucosa. They are often used for patients with swallowing difficulties or those who do not cooperate with taking medication. Previously, Lunan Pharmaceutical had launched bilastine tablets (specifications: 20mg), and the approval of this product will provide a new option for clinical use.
 

On September 19, Zhejiang Xianju Pharmaceutical Co., Ltd. announced that the company had received the "Drug Registration Certificate" for estradiol tablets issued by the National Medical Products Administration.The first in ChinaEstradiol Tablets, with a specification of 1mg, has as its reference listed drug the Estradiol Tablets (brand name: ESTRADIOL) marketed in the United States. The indications for Estradiol Tablets include diseases associated with estrogen deficiency and the prevention of osteoporosis. The specification of the company’s Estradiol Tablets is consistent with that of the reference listed drug and the originally approved marketed specification, and it has been approved as a Category 4 chemical drug.
 

On September 16, Fangu Pharmaceutical's Trazodone Hydrochloride Sustained-Release Tablets were approved, mainly used for the treatment of depression and anxiety disorders accompanied by depressive symptoms, as well as emotional disorders after drug withdrawal.The first in ChinaImitation. It is reported that trazodone hydrochloride tablets were originally developed by Angelini Pharma. In 2010, the sustained-release formulation of trazodone hydrochloride received FDA approval for marketing in the United States, and it was launched in China in 2020 for the treatment of depression.
 

On September 15, the injectable Degarelix Acetate (brand name: QingliShu®), independently developed by Chia Tai Tianqing, was officially approved for marketing by the National Medical Products Administration (NMPA) for prostate cancer patients requiring androgen deprivation therapy. This product is the first generic drug of its kind. Prostate cancer is one of the common tumors of the male urinary and reproductive systems. As a GnRH antagonist, Degarelix Acetate exerts its therapeutic effect by inhibiting testosterone release. Since the original drug was launched in 2008, it has been recommended for use in multiple international guidelines. As an important strategic achievement of Chia Tai Tianqing, the research, development, and market launch process of Degarelix Acetate demonstrates the company's comprehensive capabilities in pharmaceutical R&D and quality system challenges.
 

On September 9, Runsheng Pharmaceutical's Fluticasone Propionate Inhalation Powder was approved for marketing in China.First in ChinaFluticasone Propionate Inhalation Powder is mainly used for the maintenance treatment of patients with mild to moderate asthma. The approval and marketing of this product marks a significant milestone for Runsheng Pharmaceutical inHigh-endThe first major technological breakthrough in the field of inhalation powder aerosols will bring more efficient, convenient, and safer treatment options for asthma patients.
 

Throughout September, the dense approval trend in the generic drug market not only demonstrated the rapid development of pharmaceutical companies in China in the field of generic drug research and development but also reflected the industry's response to unmet clinical needs. In the future, with the continuous advancement of the consistency evaluation work on the quality and efficacy of generic drugs, along with the continuous improvement of companies' R&D capabilities, the domestic generic drug market is expected to embrace broader development opportunities.
 

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