After much anticipation, the "top scorer" and "second place" for Brexpiprazole Tablets have finally been decided!Attention Index:★★★★★
Brexpiprazole is a third-generation antipsychotic drug co-developed by Lundbeck and Otsuka Pharmaceutical. It received its first FDA approval in 2015 and has been approved for three major indications: schizophrenia, adjunctive treatment for depression, and agitation associated with Alzheimer's disease. In 2018, Brexpiprazole was successively approved for marketing by PMDA and EMA. On June 25, 2024, NMPA approved the original imported product.Brexpiprazole's global sales exceeded $2.023 billion (approximately RMB 14.313 billion) in 2023, making it one of the best-selling psychiatric drugs worldwide. Companies in China are actively positioning themselves in this market.According to the Generics Database of PharmaBlock, the number of accepted applications for Brexpiprazole Tablets has exceeded 100, including domestic pharmaceutical giants such as Kelun, CSPC, and Qilu Pharmaceutical. The production application by Chengdu Easton Bio Pharmaceuticals Co., Ltd. was approved on December 3, successfully securing the first generic approval for this drug. According to the Patent Database of PharmaBlock, the core patent for this drug will expire in April 2026. Easton Bio’s "first generic" success positions it perfectly at the patent cliff period, gaining a first-mover advantage for market penetration after the product launch. Qilu Pharmaceutical followed closely and was successfully approved on the 9th, becoming the second company to pass the evaluation for this drug. Notably, Qilu Pharmaceutical strategically developed a 0.5mg specification, potentially targeting the pediatric and adjuvant treatment markets.
The New 3 Billion Anticoagulant King Rivaroxaban Upgraded Again, Guilin Pharma Secures the First Generic Dry Suspension!Attention Index:★★★★Rivaroxaban is a novel anticoagulant that primarily works by inhibiting the activity of coagulation factor Xa, thereby reducing the generation of thrombin (coagulation factor IIa) while exerting its anticoagulant effect without affecting the activity of already generated thrombin. Its sales in China exceeded 3 billion yuan in 2024, with a year-on-year increase of 8.01% in H1 2025, making it one of the top three generic drugs by sales volume for antithrombotic chemical medications.Pharmacodia data shows that there are currently four formulations of Rivaroxaban approved for marketing: Rivaroxaban Tablets, Rivaroxaban Granules, Rivaroxaban Orally Disintegrating Tablets, and Rivaroxaban Dry Suspension. Among them, Guilin Pharma's Rivaroxaban Dry Suspension was recently approved, achieving the first generic version and the first to pass the evaluation. Data indicates that this drug is suitable for the treatment of venous thromboembolism and prevention of recurrence in full-term newborns, infants, children, and adolescent patients under 18 years old after initiating standard anticoagulation therapy, providing a new anticoagulant treatment option for more pediatric patients.In China, as of December 2025, no domestically produced entrectinib capsules have been approved for marketing according to publicly available information; only Qilu Pharmaceutical Co., Ltd. submitted a new Category 4 production application to the CDE this week.
Battle of the Titans! Original Research Just Arrived and Was "Surrounded", Pemafibrate's First Generic Record May Be Broken AgainPemafibrate (Parmodia), a novel and highly selective peroxisome proliferator-activated receptor α (PPARα) modulator, was originally developed by Kowa Company in Japan. It received PMDA approval and was first launched in Japan in July 2017 for the treatment of hyperlipidemia. In June 2023, a new extended-release formulation of pemafibrate was approved in Japan for the treatment of hyperlipidemia (including familial hyperlipidemia). Compared to the twice-daily dosing of regular pemafibrate tablets, the extended-release formulation offers greater convenience with just once-daily oral administration. On April 8, 2025, pemafibrate tablets received NMPA approval for import and officially entered the Chinese market.According to relevant data statistics, just three years after the launch of Pemafibrate Tablets, it surpassed Fenofibrate. Its sales reached 65.1 million US dollars in 2020 and increased to 112 million US dollars in 2023, with an annual growth rate of over 10%. Such a rapid growth trend has attracted the attention of numerous pharmaceutical companies in China. A first generic application was submitted only nine days after the original drug's market launch, setting a record for the shortest time difference between the original drug and its first generic application. According to the Generics Database by Yidu Data, multiple domestic companies have successively submitted new Category 4 production applications for Pemafibrate Tablets. Among them, Zhengdatianqing became the first domestic company to submit such an application. This week, Jiangxi Taijili / Zhejiang Yihan Pharmaceutical submitted a new Category 4 production application for Pemafibrate Tablets, competing with many other applicants for the first generic approval. Who will secure the first generic approval remains to be seen, and Yidu Data will continue to monitor the situation.Development and Approval Dynamics of Generic Drugs in China
First Approval and Market Launch of New Registration Classification VarietiesAccording to the PharmaData research, during this statistical period (December 6-12, 2025), six new registration classifications received their first approval, involving three varieties, including two tablets and one dry suspension. Compared with the previous statistical period, three new registration classification varieties received their first approval this time.
New Registration Classification: First to Pass Evaluation
Brexpiprazole is a third-generation antipsychotic drug jointly developed by Lundbeck and Otsuka. It acts as a partial agonist at serotonin 5-HT1A receptors and dopamine D2 and D3 receptors, and also as a partial antagonist at serotonin 5-HT2A and 5-HT2B receptors, as well as adrenergic α-1 and α-2 receptors. Brexpiprazole exhibits high affinity for these receptors.In July 2015, Brexpiprazole was approved by the FDA for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder; in May 2023, the FDA announced the approval of brexpiprazole for expanded indications to treat agitation associated with dementia due to Alzheimer’s disease. In 2018, brexpiprazole was successively approved by the PMDA and EMA. On June 25, 2024, the NMPA approved the original imported product.According to the Generics Database research by PharmaDJ, currently in China, only the original research company, China OTSUKA Pharmaceutical Co., Ltd., holds the production approval for Brexpiprazole Tablets. Chongqing Youfriend, Chengdu Easton Bio Pharmaceuticals Co., Ltd., Harbin SANLI Pharmaceutical Co., Ltd., Shenzhen Fangu Pharmaceuticals, Kunshan Longden RuDi, and Nanjing Zhengke Pharmaceutical respectively submitted applications for the production of Brexpiprazole Tablets in 2021 and 2024, but all were rejected.
Due to space limitations, only the progress of the first five companies' applications is shown. For more information, please check the Generics Database on PharmaDATA.Pharmacodia Data-The patent library information shows that the compound patent for Brexpiprazole will2026Year4Monthly expiration, major pharmaceutical companies are competing to make strategic moves. PharmaData-Information from the Chinese registry shows that major companies are flocking to report the production of Brexpiprazole Tablets. Chengdu Easton Bio Pharmaceuticals Co., Ltd.12Month3Ribo took the lead and successfully won the "first generic" title for this variety. Qilu Pharmaceutical followed closely, with its production application...9Deemed to have passed on the same day, becoming the2Companies that have passed domestic evaluations. It is worth mentioning that Qilu Pharmaceutical has implemented a differentiated layout.0.5mgSpecifications, or for expanding the children and adjuvant therapy market. Other companies' production applications are still in the review and approval process.
Acceptance Status of New Registration Classification for Brexpiprazole Tablets (Partial)
Since its launch, Brexpiprazole Tablets have maintained a growth trend for nearly a decade. The global sales of Brexpiprazole in 2023 exceeded $2.023 billion (approximately RMB 14.313 billion), making it one of the best-selling psychiatric drugs worldwide.Schizophrenia is a mental disorder with a high disability rate, affecting at least about 1% of the global population. Its clinical features include positive symptoms (hallucinations, delusions), negative symptoms (emotional flatness, social dysfunction), and cognitive impairments. While there are currently clinical drugs available to treat positive symptoms, there remains a lack of effective treatments for negative symptoms and cognitive impairments, which have long-term impacts on patients' social functioning and quality of life.Relevant studies show that Brexpiprazole is not only effective in improving the symptoms of schizophrenia, but also in preventing its recurrence. Meanwhile, Brexpiprazole has good safety and tolerability, and long-term use is expected to reduce the risks of extrapyramidal side effects, hyperprolactinemia, weight gain, psychosis, insomnia, nausea/vomiting, or agitation, which may help patients reintegrate into society. We look forward to the early mass production and market launch of domestically produced generic drugs, providing better treatment options for psychiatric patients in China.First Approval and Market Launch of Consistency Evaluation VarietiesAccording to the PharmaBlock data research, there were no newly accepted applications for the first batch of consistency evaluations during this statistical period (December 6, 2025 - December 12, 2025). The number of first-batch consistency evaluation varieties added during this statistical period remained the same as the previous one.Approval Status of Newly Registered Classification ProductsAccording to the PharmaBlock data research, during this statistical period (December 6, 2025 – December 12, 2025), there were 165 newly registered classification approval numbers added, involving 105 varieties, including 38 tablets, 37 injections, 1 liniment, 1 drops, 4 eye drops, 1 dry suspension, 1 enema, 1 suspension, 8 capsules, 2 granules, 7 oral solutions, 1 oral emulsion, 1 cream, 1 powder, and 1 inhalation solution. Compared with the previous statistical period, this time saw an increase of 105 newly registered classification approval varieties.
New Registration Classification Approval Status (Partial)Status of Consistency Evaluation Product Approvals for Market LaunchAccording to the PharmaData research, during this statistical period (December 6-12, 2025), 16 new acceptance numbers for passing the quality consistency evaluation were added, involving 11 varieties, including 3 tablets and 8 injections. Compared with the previous statistical period, the number of varieties passing the consistency evaluation has increased by 7.
Consistency Evaluation of Selected Products
Status of Approval for Generic Drug Clinical TrialsStatus of Rejection/Active Withdrawal of Generic Drug VarietiesR&D and Application Trends of Generic Drugs in China
Status of New Registration Classification Product Applications for Market LaunchAccording to the PharmCube data research, during this statistical period (December 6, 2025 - December 12, 2025), the new registered classification data increased by 77.A new application number involves 55 varieties, including 21 tablets, 15 injections, 1 nasal spray, 1 liniment, 1 ear drop, 1 eye drop, 1 dry suspension, 1 suspension, 5 capsules, 2 oral solutions, 1 gel, 1 cream, 1 ointment, 1 syrup, 1 inhalation powder, and 1 lotion. Compared with the previous statistical cycle, this time there are 12 fewer newly registered classified declaration varieties.
Acceptance Status of New Registration Classification Applications (Partial)
Status of Consistency Evaluation Product Submissions for Market ApprovalAccording to the PharmaBlock data research, in this statistical cycle (December 6, 2025 - December 12, 2025), there are 15 newly accepted application numbers for consistency evaluation, involving 10 varieties, including 6 tablets, 3 injections, and 1 granule. Compared with the previous statistical cycle, 4 more varieties have been added for consistency evaluation applications.
Acceptance Status of Consistency Evaluation Applications (Partial)
Status of Generic Drug Supplemental ApplicationsSummary of Patent Statements for Generic Drug ApplicationsGeneric Drugs in ChinaR&D Field Hotspots Focus
Policy and Regulatory Updates in China's Generic Drug Development Field
Announcement of Protected Traditional Chinese Medicine Varieties (No. 32) (No. 116, 2025)
According to the Regulations on the Protection of Traditional Chinese Medicine Varieties, the National Medical Products Administration has approved Qinxiang Qingjie Oral Liquid from First Flower Bio-pharmaceutical Co., Ltd. and Tiandan Tongluo Tablets from Shandong Phoenix Pharmaceutical Co., Ltd. as the first TCM second-level protected varieties. The protection variety numbers are ZYB2072025031 and ZYB2072025032, respectively. The protection period is seven years from the date of this announcement. This is hereby announced.Hot News in China's Generic Drug R&D Field
Renfu Pharmaceutical: Announcement of Renfu Pharmaceutical on the Approval of Midazolam Injection by the German Federal Institute for Drugs and Medical Devices (BfArM)
On December 12, Renfu Pharmaceutical Group Co., Ltd. announced that its holding subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., had received the marketing authorization approval letter for Midazolam Injection issued by the German Federal Institute for Drugs and Medical Devices (BfArM). The main details are hereby announced as follows:Midazolam QbD Group Austria 1mg/ml Injektions-/InfusionslsungMidazolam QbD Group Austria 5mg/ml Injektions-/InfusionslsungSpecification: 1mg/ml (Fill Volume: 5mL) and 5mg/ml (Fill Volume: 1mL, 3mL, and 10mL)Manufacturer: Yichang Humanwell Pharmaceutical Co., Ltd.Midazolam Injection Receives Marketing Authorization from Germany’s Federal Institute for Drugs and Medical Devices (BfArM)The approved indications include: 1) Conscious sedation before, during, and after diagnostic or therapeutic procedures (with or without local anesthesia); 2) Pre-anesthetic medication in adults prior to anesthesia induction, anesthesia induction, and use as a sedative in combination with other anesthetics; pre-anesthetic medication in children prior to anesthesia induction; 3) Sedation in the Intensive Care Unit (ICU). Yichang Renfu submitted the marketing authorization application for Midazolam Injection to France’s National Agency for Medicines and Health Products Safety (ANSM) and Germany’s Federal Institute for Drugs and Medical Devices (BfArM) simultaneously under the Decentralized Procedure (DCP) in December 2023. The application was accepted, received marketing approval from France’s ANSM in June 2025, and now has obtained approval from Germany’s BfArM, with a five-year validity period. The total investment for this project’s registration in France and Germany is approximately RMB 10 million. According to IQVIA data statistics, the annual sales of Midazolam Injection in the German market were approximately USD 7 million in 2024, with major manufacturers including TEVA, HAMELN, and ETHYPHARM.After the midazolam injection obtained the marketing authorization from Germany's BfArM this time, it can be sold in Germany, which will have a positive impact on the company's international business expansion.Little D Has Something to Say
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