南宫NG28

Service Background

As of July 2024, more than 20 domestic companies have imitated Cyclosporine (oral/injectable dosage forms). In 2023, the total market value of the market was 1.9 billion CNY, of which soft capsules accounted for 1.7 billion CNY.
In 2023, the total domestic market value of Tacrolimus dosage forms was 6.3 billion CNY, of which capsules accounted for 6.1 billion CNY and sustained-release capsules accounted for 160 million CNY. Tacrolimus sustained-release capsules have obvious advantages over ordinary capsules: improved renal function, stable blood drug concentration; positive impact on drug economy; effective control of blood sugar and triglyceride levels, reduced cardiovascular risks and gastrointestinal discomfort. Only need to be taken once a day.

Technology transfer of Tacrolimus sustained-release capsules

Generic name: Tacrolimus
Indications: Prevention of graft rejection after kidney transplantation. Prevention of graft rejection in the maintenance period after liver transplantation. Treatment of graft rejection after kidney or liver transplantation that cannot be controlled by other immunosuppressive drugs.
Dosage form: 0.5 mg, 1 mg
Usage and dosage: Once a day, take in the early morning. Take it on an empty stomach, at least 1 hour before or 2 ~3hours after food.
Reference formulation: Tacrolimus sustained-release capsules, Astellas, Advagraf®/Sinograf®, original research and import
Marketing status: 2007 (Europe), 2010 (China)
Patent status: Preparation formulation CN99806415 expired in 2019, no patent research and development risk
Registration category: New Class 4 application
National centralized procurement: None
Medical insurance status: Class B medical insurance

Treatment status and future trends

In order to improve the long-term survival rate of liver and kidney transplants, patients need to take immunosuppressants for a long time, including immune-inducing formulation (such as monoclonal or polyclonal antibodies) used to reduce acute rejection reactions in the early stage of transplantation, and maintenance treatment drugs for long-term prevention of rejection reactions (such as calcineurin inhibitors Tacrolimus, Cyclosporine, etc.). As the first-line anti-rejection drug, tacrolimus is the first choice due to its small dosage, strong efficacy and few adverse reactions. Most solid organ transplant patients use tacrolimus maintenance treatment.

The popularity and progress of R&D

As of July 2024, there are 18 API companies and 2 pharmaceutical formulation companies (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. and Chengdu Suncadia Medicine Co.,Ltd.) have been registered or passed the review. Among them, 5 are in the process of registration, and another 5 have completed BE registration. Tacrolimus sustained-release capsules have attracted attention due to their high technical difficulty. CTI Pharma and Medical Services CMC Service already has a mature production process and provides secondary development services.

Our advantages

● International recognition: As a first-line anti-rejection drug, Tacrolimus has better efficacy and safety than Cyclosporine;
● Superior properties: The sustained-release capsule form improves safety and ease of use, and only needs to be taken once a day;
● Simplified process: For Category 4 generic drug applications, only BE studies are required;
● Technical barriers: As a high-difficulty generic drug in the industry, it has certain technical thresholds;
● Mature technology: CTI Pharma and Medical Services has perfect production technology and secondary development capabilities.

Service process