Qilu Pharmaceutical Secures First Domestic Approval for Billion-Dollar Blockbuster Drug Tafamidis Meglumine Soft Capsules

Last week (June 10th to June 16th), a total of 60 varieties passed/were considered to have passed the consistency evaluation. Among them, the first generic drugs included Qilu Pharmaceutical Co., Ltd.'s Tafamidis Methylglucamine Soft Capsules, Jumpcan's Fexofenadine Hydrochloride for Oral Suspension, and Chengdu Guowei Biomedical Co., Ltd.'s Calcitriol Injection. During the same period, 68 varieties applied for the consistency evaluation.

Heavyweight First Generic
Qilu, Jumpcan, Guowei

According to the NMPA official website, Qilu Pharmaceutical's Tafamidis Meglumine Soft Capsules, Jumpcan's Fexofenadine Hydrochloride for Oral Suspension, and Guowei Biotech's Calcitriol Injection all received marketing approval on June 11.

Patisiran Sodium Soft Capsules

Qilu Pharmaceutical's chlorbenzamide soft capsules are the first domestically produced generic + the first to pass the evaluation in China. This drug is a treatment for rare diseases, originally developed by Pfizer as tafamidis (brand name: VYNDAQEL; Vyndaqel).

Vidacut is an oral formulation of a transthyretin stabilizer, which was approved for marketing in China in February 2020. It is used to treat adult patients with stage I symptomatic transthyretin amyloidosis polyneuropathy (ATTR-PN) to delay peripheral nerve damage.

ATTR-PN is a hereditary, rare, fatal neurodegenerative disease that often involves multiple systems. The main manifestations are symmetrical neurological dysfunction progressing from the distal to the proximal limbs, which can affect motor, sensory, and autonomic nerves, and may also involve damage to other organs such as the heart, kidneys, and eyes. ATTR-PN typically affects adult patients, gradually progressing to the terminal stage about 10 years after onset. Due to its clinical features being easily confused with other common diseases, coupled with the rarity of cases and limited awareness among clinicians, opportunities for pathological and genetic diagnosis are also restricted, leading to diagnostic delays. According to publicly available data, since its approval and market launch, Vyndaqel's annual sales have continued to rise, exceeding $3 billion globally in 2023 (over 22 billion RMB).

Qilu Pharmaceutical's Tafamidis Methylglucamine Soft Capsules Successfully Approved for Marketing in China, Expected to Bring More Options for Chinese ATTR-PN Patients.

Fexofenadine Hydrochloride for Suspension

Jumpcan's Fexofenadine Hydrochloride for Oral Suspension is the first approved dry suspension formulation of fexofenadine in China. This product is suitable for alleviating symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in children over 6 months and adults.

Fexofenadine Hydrochloride is a second-generation H1 receptor antagonist with excellent antihistamine effects. According to reports, the dry suspension formulation recently approved for Jumpcan combines the characteristics of solid formulations (granules) with the advantages of liquid formulations. It is portable, highly stable, and easy to take, making it especially suitable for children and elderly patients with swallowing difficulties. This improves the medication experience for patients, with precise dosage instructions tailored to each age group, providing better guidance for rational drug use. Additionally, the drug uses unique taste-masking technology to enhance palatability.

Jumpcan's Fexofenadine Hydrochloride for Oral Suspension Approved for Marketing in China, Offering More Options for Patients with Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria, Especially for Children and Elderly Patients.

Calcitriol Injection

Guowei Biotech's Calcitriol Injection is the first domestically produced generic and exclusive product in China, used for treating hypocalcemia and/or secondary hyperparathyroidism in chronic renal dialysis patients.

According to publicly available data, by the end of 2022, more than 840,000 patients were registered for hemodialysis in China, with the incidence of secondary hyperparathyroidism (SHPT) exceeding 60%. Calcitriol is recommended as a first-line treatment for SHPT by authoritative guidelines both domestically and internationally, and is highly recognized by clinicians. Guowei Biotech's formulation improvements, from oral to injectable forms, have significantly enhanced the drug’s bioavailability, improved the efficacy in lowering parathyroid hormone (PTH), and thereby increased medication adherence among hemodialysis patients.

Guowei Biotech stated that the approval of Calcitriol Injection provides patients with a new treatment option, while further enriching its nephrology-related product line.

Status of Consistency Evaluation

From June 10 to June 16, a total of 60 varieties passed/were considered to have passed the consistency evaluation.

Among them, Rivaroxaban Fine Granules from Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. and Zhejiang Saimo Pharmaceutical Co., Ltd., and Isoproterenol Hydrochloride Injection from Chengdu Xinjie High-tech Development Co., Ltd. and Emeishan Tonghui Pharmaceutical Co., Ltd. are exclusive products of the companies.

Details of other varieties are as follows:

Table 1: Varieties passing the consistency evaluation from June 10 to June 16

Source: Yaoke Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Table 2: June 10 to June 16, Products Deemed to Have Passed the Consistency Evaluation

Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Acceptance Status of Consistency Evaluation

From June 10 to June 16, a total of 68 varieties applied for consistency evaluation. The specific situation is as follows:

Table 3: June 10 to June 16, Status of Consistency Evaluation Submissions

Source: Yaoke Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Editor: Mu Mian

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