Qilu Pharmaceutical Achieves Major Milestone with Five First-to-File Generic Drugs in 2024 Amid National Surge of 65 Approvals

　　【Pharmaceutical Network Industry DynamicsIn recent years, China has seen frequent favorable policies in the pharmaceutical field, including strong support for domestically produced high-quality generic drugs, injecting significant vitality and opportunities into the industry. According to data, as of now, the number of first-approved generics in China (counted by product name + company name, including those approved on the same day) in 2024 has reached a cumulative total of 65.
 

As of July 19, Qilu Pharmaceutical has obtained 5 first-to-market generic drugs in 2024.
 

Among them, Qilu Pharmaceutical's Entrectinib Tablets (Tweino), used for treating HIV-1 (Type 1 Human Immunodeficiency Virus) infection, was approved for marketing on July 16. The reference drug for this product is Gilead's Odefsey, with global sales of the original drug exceeding $1.3 billion in 2023. Currently, the original drug has not yet entered the Chinese market.
 

Data show that Enquadrilipin Tablet is composed of emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate. Emtricitabine is a nucleoside reverse transcriptase inhibitor that can block the synthesis of viral DNA chains. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that inhibits viral replication by non-competitively inhibiting HIV-1 reverse transcriptase and exhibits broad-spectrum antiviral activity against various HIV-1 subtypes. Tenofovir alafenamide is converted into the active form tenofovir in the body, and then transformed into tenofovir diphosphate through phosphorylation, inducing termination of viral DNA chain replication. The combination regimen of these three drugs has proven efficacy and is a recommended treatment option for initial antiviral therapy in adult and adolescent patients according to guidelines. The single-tablet formulation is more convenient to take, requiring only one tablet per day, which helps reduce the medication burden on patients and improve adherence.
 

In June, Qilu Pharmaceutical secured two first-to-market generic drugs: Tafamidis Meglumine Soft Capsules and Metformin Empagliflozin Tablets (VI).
 

Among them, the original research company of Tafamidis Meglumine Soft Capsules is Pfizer. This drug can be used to treat adult patients with stage I symptoms of transthyretin amyloidosis polyneuropathy (ATTR-PN) and can effectively delay peripheral nerve function damage. Data shows that the global sales of Pfizer's Tafamidis series in 2023 exceeded 3.3 billion US dollars.
 

Metformin Empagliflozin Tablets (Pinghui'an®) are used to improve glycemic control in adult patients with type 2 diabetes. Data shows that Metformin Empagliflozin Tablets are a compound preparation consisting of empagliflozin and metformin hydrochloride. Metformin is a cornerstone hypoglycemic agent consistently recommended by guidelines both in China and internationally. The combination of empagliflozin and metformin can address different pathophysiological defects of type 2 diabetes, exerting complementary mechanisms and synergistic hypoglycemic effects, which are more conducive to maintaining glycemic control. Additionally, it can bring multiple benefits to the cardiovascular system, kidneys, and metabolism, delaying the onset and progression of complications.
 

In May, Qilu Pharmaceutical's concentrated solution for injection of bendamustine hydrochloride was approved. This drug is characterized by low toxicity, high activity, and a broad-spectrum antitumor effect, and is suitable for treating various hematologic malignancies such as indolent B-cell non-Hodgkin lymphoma. This product is a new formulation of bendamustine, and compared with the traditional lyophilized powder injection, the concentrated solution for injection of bendamustine hydrochloride does not require reconstitution before use, making clinical operation more convenient.
 

In January, Qilu Pharmaceutical's Eltrombopag Ethanolamine Tablets were approved for marketing. It was reported that on the same day, the companies Jiangsu Aosaikang Pharmaceutical, Zhengda Tianqing Pharmaceutical, and Sichuan Kelun Pharmaceutical also received approval for the product. Data shows that Eltrombopag Ethanolamine Tablets are a non-peptide thrombopoietin receptor agonist developed by Novartis Pharmaceuticals. It received approval from the U.S. Food and Drug Administration (FDA) in November 2008 and was approved to enter the Chinese market in 2017, used for treating chronic immune (idiopathic) thrombocytopenia (ITP) patients who have had inadequate responses to treatments such as corticosteroids and immunoglobulins.
 

In addition to Qilu Pharmaceutical, Jiangxi Simo Pharmaceuticals and Wuhu Daorun Pharmaceuticals each have four first-to-market generic drugs. Among them, Jiangxi Simo Pharmaceuticals obtained Rivaroxaban Granules in March this year, Telmisartan Amlodipine Tablets in June, and Irbesartan Amlodipine Tablets (Ⅰ) and Irbesartan Amlodipine Tablets (Ⅲ) in July. Moreover, Zhongda Pharmaceutical has three first-to-market generics, and Kelun Pharmaceutical, Aosaikang, and Yipinhong also secured first-to-market generics. According to the summary, the first-to-market generics of three products with over 1 billion yuan in sales were obtained by Zhongdaqingjiang, Shiyao, and Health Yuan.