24 First-to-Pass Generic Drugs Approved in January, Led by Qilu Pharmaceutical, Kelun Pharma, and Hengrui Medicine

　　【Pharmaceutical Network Industry Dynamics】According to data statistics, in January, 233 varieties passed/were considered to have passed the consistency evaluation, of which 24 varieties were the first to pass. The companies involved include Qilu Pharmaceutical, Kelun, Renfu Medicine, Fosun Pharma, Hengrui Medicine, Shijiazhuang Sihua Pharmaceutical, etc.
 

On January 8, according to the latest information on the NMPA website, Qilu Pharmaceutical (Hainan) received approval for the market launch of its Ibrutinib Tablets, filed under Registration Classification 3. This is the first generic version of this formulation, considered as having passed the evaluation. Ibrutinib is a BTK inhibitor, primarily used for treating Mantle Cell Lymphoma (MCL), originally developed by Johnson & Johnson in collaboration with Pharmacyclics. Additionally, Qilu Pharmaceutical's Ixazomib Citrate Capsules are also the first product to pass the evaluation.
 

On January 8, Kelun Pharmaceutical announced that its Lusutrombopag Tablets had recently received drug registration approval from the National Medical Products Administration. This drug belongs to Category 4 chemical medicines and is in tablet form. Lusutrombopag Tablets, developed by Shionogi, are a new generation of orally administered small-molecule thrombopoietin receptor agonists (TPO-RA) used for adult patients with chronic liver disease and thrombocytopenia who are scheduled for surgery. In addition, Kelun Pharmaceutical's Imipenem and Cilastatin Sodium for Injection/Sodium Chloride Injection was also the first product to pass the evaluation.
 

On January 9, Fuyuan Pharmaceutical announced that its wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., had recently obtained the drug registration certificate for Diclofenac Diethylamine Emulgel issued by the National Medical Products Administration. The drug is registered as Category 4 chemical medicine. This medication is used to relieve mild to moderate pain in muscles, soft tissues, and joints, and can also be used for symptomatic treatment of osteoarthritis.
 

On January 15, Renfu Pharmaceutical announced that its holding subsidiary, Yichang Renfu Pharmaceutical, had recently received the "Drug Registration Certificate" for Midazolam Maleate Tablets issued by the National Medical Products Administration. The indications for this drug are sleep disorders and insomnia, and it is particularly suitable for people who have difficulty falling asleep, as well as for preoperative or pre-diagnostic medication.
 

On January 20, it was reported that the marketing registration application for Oxazepam Tablets by Hunan Dongting Pharmaceutical Co., Ltd., a holding subsidiary of Fosun Pharma, was recently approved by the National Medical Products Administration. The drug is in tablet form, with a specification of 15mg, and is registered as a Category 3 chemical drug. It is mainly used for the short-term relief of symptoms such as anxiety, tension, and agitation.
 

On January 20, Shijiazhuang No.4 Pharmaceutical Group announced on the Hong Kong Stock Exchange that the group had obtained the drug production registration certificate from the National Medical Products Administration for Compound Potassium Phosphate Injection (5ml), classified as Chemical Drug Category 3. Compound Potassium Phosphate Injection is a compounded preparation mainly used to correct hypophosphatemia in adult and pediatric patients when oral or enteral nutrition cannot be administered, is insufficient, or is contraindicated, and for parenteral nutrition in adult and pediatric patients.
 

On January 20, Hengrui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., had received the "Drug Registration Certificate" for Compound Amino Acids (16AA)/Glucose (12.6%) Electrolyte Injection issued by the National Medical Products Administration. The approved indication is to provide parenteral nutrition for adult patients when enteral nutrition is not feasible, insufficient, or contraindicated, supplementing amino acids, electrolytes, and glucose.
 

In January, Xinhua Pharmaceutical received the "Drug Supplemental Application Approval Notice" for Tramadol Hydrochloride Sustained-Release Tablets issued by the National Medical Products Administration. The product has passed the quality and efficacy consistency evaluation for generic drugs, and Xinhua Pharmaceutical is the first company in China to have passed. Tramadol Hydrochloride Sustained-Release Tablets are opioid analgesics that act centrally and are indicated for moderate to severe pain.
 

In addition, the varieties that received approval in January include Shanghai Fenglin Biotechnology's Sodium Citrate Hemofiltration Replacement Solution; Henan Zhongshuai Pharmaceutical's Dextroamphetamine Hydrochloride Sustained-Release Capsules; Mingrui Pharmaceutical's Policresulen Solution; Dagguang Pharmaceutical's Maleic Acid Pheniramine Hydrochloride Naphazoline Eye Drops; Nuotai Aosainuo's Ezetimibe Atorvastatin Calcium Tablets (I); Shenlian Pharmaceutical's Cyclopentolate Hydrochloride Eye Drops; Nuoa Pharmaceutical's Amorolfine Hydrochloride Lotion; Pharmaxing Pharmaceutical's Clobicin Gel Patch; Jichuan Pharmaceutical's Sitafloxacin Granules; Bausch + Lomb Freda Pharmaceutical's Carbachol Injection; Yikang Pharmaceutical's Atenolol Injection; Taidi Pharmaceutical's Tulobuterol Patch; Taifeng Biotechnology's Menatetrenone Soft Capsules, etc.
 

The industry stated that the approval of these drugs marks that the relevant companies are qualified to produce and sell the drugs in the Chinese market, further enriching the company's product line. The market launch and sales will have a positive impact on the company.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.