China Rivaroxaban powder API 鈥?Development History On December 31, 1993, Hangzhou Jiuyuan Gene Engineering Co., Ltd. was registered and established in Hangzhou New High-tech Development Zone. On October 14, 1996,the company obtained the Trial-production Approval Number and New Drug Certificate of JILIFEN, the first rhG-CSF injection in China, making China become the third country able to manufacture the drug in large volumes following in the U.S and Japan. In June, 1998, the drug low molecular weight heparin sodium injection (JIPAILIN) was approved for production and marketing by Ministry of Health. On September 18, 2003,the company achieved a New Drug Certificate and Manufacture Approval of JIJUFEN, a platelet promoting drug (Recombinant Human Interleukin 11). In July, 2006, the company initiated the production and sales of the 4th product YINUOJIA (Enoxaparin Sodium Injection), indicating the first officially approved enoxaparin was born in China. The company was awarded as one of the first "National High-Tech Enterprises" in 2008. On December 19, the 5th product JIOUTING (Palonosetron Hydrochloride API and injection) officially got approval for manufacture. In 2010, the new product recombinant human bone repair material BMP-2 (GUYOUDAO) was manufactured and launched on market. In October, 2013,the company reformed marketing system and established a development strategy of "Marketing First, Total Marketing". In 2018, the company has initiated a major transformation, focusing on both innovative and generic drugs. In 2020, R&D center moved to Hangzhou Medicine valley. The company's sales exceeded 1 billion yuan. 鈥?Company Profile Hangzhou Jiuyuan Gene Engineering Co., Ltd. is a modern biopharmaceutical company, specialized in R&D, manufacture and sales of gene engineering, biochemical, chemical drugs and medical device. The company was founded in December 1993 as a member of Huadong Medicine Group, and became one of the earliest gene engineering pharmaceutical enterprises in Zhejiang province as well as in China. The company always upholds the concept "Taking gene engineering as orientation, Rendering service to human health", to pursue innovation and to strive for excellence. In October 1996, the company took the lead in successful development and industrialization of a leukocyte promotion medicine named JILIFEN (Filgrastim, rhG-CSF), entered the market monopolized by U.S and Japanese manufacturers and won a praise of "First Injection in China". Over the twenty years, the company has actively propelled the progress of biopharmaceutical industrialization, gradually developed a series of products including JILIFEN, JIPAILIN, JIJUFEN, YINUOJIA, JIOUTING and GUYOUDAO and so on. In 2020, R&D center and part of production line have moved to Hangzhou Medicine Valley, the level of software and hardware in R&D and production have been improved. With the help of Academician expert station, postdocotoral workstation and other scientific research platforms, Jiuyuan devoted all the efforts to developing macromolecular drugs of insulin and monoclonal antibody. The company successively acquired various honors like National New High-tech Enterprise, Key New High-tech Enterprise of National Torch Plan, Second Class Prize of Provincial Scientific-technical Progress, Provincial Famous Trademark, Provincial High-tech Research and Development Center and so on. The company exerts open and aggressive spirit, accumulates numerous resources, absorbs worldwide quintessence, Strive to create a product structure dominated by scientific research and development and technological innovation, mainly to develop biological products, and develop high-end chemical products and innovative drugs as a supplement. Strive to support innovative pharmaceutical industrial enterprises with a relatively complete national market network that focuses on both the basic level market and the central city market. 鈥?Product Application JILIFEN [Name] Generic Name: Filgrastim Trade Name: JILIFEN Chemical Name: Human Granulocyte-Colony Stimulating Factor (hG-CSF) Injection The first human granulocyte stimulating factor in China; Approved by German GMP international certification. The only one hG-CSF that has been validated by clinical trial phase III. The quality of recombinant protein reached the standard of EP and USP. Dosage: Injection Specification Ampoule: 50渭g(0.2 ml: 4脳106IU), 75渭g(0.3ml: 6脳106IU), 100渭g(0.4 ml: 8脳106IU), 150渭g(0.6 ml: 1.2脳107IU), 200渭g(0.8 ml: 1.6脳107IU), 300渭g(1.2ml: 2.4脳107IU), 450渭g(1.8ml: 3.6脳107IU) Pre-filled syringe: 75渭g (0.25ml: 6脳106IU), 150渭g(0.5ml: 1.2脳107IU), 300渭g(0.5ml: 2.4脳107IU) [Indication] 1. To enhance neutrophil counts after bone marrow transplantation; 2. Neutropenia induced by anti-cancer chemotherapy; 3. Neutropenia accompanied with Myelodysplastic Syndrome; 4. Neutropenia accompanied with Aplastic Anemia; 5. Congenital or idiopathic neutropenia. JIJUFEN [Name] Generic Name: Oprelvekin Trade Name: JIJUFEN Chemical Name: Human Interleukin-11 for Injection The only drug approved by FDA for prevention and treatment of Chemoradiotherapy-induced thrombocytopenia. Dosage: Injection Specification: 0.75mg (600MU)/vial, 1.5mg (1200MU)/vial, 3mg (2400MU)/ vial The only preparation of interleukin-11 expressed by eukaryotic cells [Indication] Prevention and treatment of Chemoradiotherapy-induced thrombocytopenia. JIOUTING [Name] Generic Name: Palonosetron Hydrochloride injection The quality and efficacy consistency of generic drugs were evaluated. The second generation 5-HT3 receptor antagonist, super antagonistic, long - lasting antiemetic. The only 5-HT3 receptor antagonist FDA-approved for the prevention of delayed chemotherapy-induced nausea and vomiting. Dosage Form: Injection Specification: 5ml: 0.25mg, 1.5ml: 0.075mg [Indication] 1. To prevent nausea and vomiting which are induced by tumor treatment (Radiothrapy or chemotherapy) 2. To prevent nausea and vomiting after anesthesia and surgery. 3. To prevent postoperative nausea and vomiting within 24 hours after surgery. JIPAILIN [Name] Generic Name: Low Molecular Weight Heparin Sodium (LMWH) Injection The first low molecular weight heparin sodium injection in China. The ideal drug for anticoagulant and antithrombotic. National basic drugs Dosage Form: Injection Specification: 0.3ml: 3000IU; 0.5ml: 5000IU; 2.0ml: 5000IU;1.0ml: 2500IU;1.0ml: 10000IU; [Indication] 1. Treatment of established deep vein thrombosis. 2. Prevention of venous thromboembolic disease (prevention of blood clot formation in the veins) in particular those which may be associated with surgery. 3. Prevention of thrombus formation in the extra-corporal circulation during hemodialysis. 4. Treatment of acute unstable angina and non-Q-wave myocardial infraction, administered concurrently with aspirin. YINUOJIA [Name] Generic Name: Enoxaparin Sodium Injection 鈼?The only LWMH is recommended by ACC, ESC and CSC to cure UA and NSTEMI. 鈼?The only LWMH is approved to cure STEMI. 鈼?The only enoxaparin sodium which complies with EP 8.0 standard, and has EU and USA process patent in China. 鈼?Consistent with structure characteristics t of original drug Lovenox/Clexane, compare with other generic drugs, YINUOJIA has highest biologically equivalent and specific value of anti-FXa/anti-FIIa activity. At low risk of bleeding and high safety. 鈼?Obtained the special project support of new medicine development form the state council, and excellence award of state patent for invention, Class B drugs of National medical insurance, Basic drugs in some provinces and cities. Dosage Form: Injection Specification: 0.4ml锛?000AxaIU锛?.6ml锛?000AxaIU [Indication] 1. Prevention of venous thromboembolic diseases, especially thrombosis associated with orthopedic or general surgery. 2. Treatment of established deep venous thromboembolic with or without pulmonary embolism. 3. Prevention of thrombus formation in the extra-corporal circulation during hemodialysis. 4. Treatment of acute unstable angina and non-Q-wave myocardial infraction, administered concurrently with aspirin. 5. Treatment of acute ST-segment elevation myocardial infarction with thrombolytics or combined with percutaneous coronary intervention (PCI). GUYOUDAO [Name] Chemical Name: Recombinant Human Bone Morphogenetic Protein-2 A new type bone repairing material which has biological activity. Specification: 0.3mg rhBMP-2/vial, 0.4mg rhBMP-2/vial, 0.4mg-鈪?rhBMP-2/vial, 0.5mg-鈪爎hBMP-2/vial, 0.5mg-鈪hBMP-2/vial, 0.6mg rhBMP-2/vial, 0.6mg-鈪爎hBMP-2/vial, 0.75mg rhBMP-2/vial, 0.8mg rhBMP-2/vial, 0.8 mg-鈪爎hBMP-2/vial, 1.0mg rhBMP-2/vial, 1.0mg-鈪爎hBMP-2/vial, 1.2mg rhBMP-2/vial, 1.5mg rhBMP-2/vial, 1.6mg rhBMP-2/vial, 2.0mg rhBMP-2/vial, 2.4mg rhBMP-2/vial, 3.0 mg rhBMP-2/vial [Indication] Indicated in filling and repairing for various reasons caused bone defect, bone non-union, delayed bone healing or unhealing, as well as treated in spinal fusion, joint fusion and orthopedic bone graft repair. 鈥?Company Honor National New High-tech Enterprise Key New High-tech Enterprise of National Torch Plan National superior enterprise of intellectual property Provincial New High-tech Research & Development Center Zhejiang Provincial Enterprise Technology Center Zhejiang Famous Trademark Zhejiang Jiuyuan Gene Engineering Biopharmaceutical Research Institute Zhejiang province per mu benefit leading enterprises Gene-engineering New Drug R&D Technology and Service Sub-platform Provincial Post-doctoral Scientific Research Working Center Excellent industrial products in Zhejiang Province Hangzhou Academician Expert Working Center Hangzhou Top Ten New High-tech Enterprise Zhejiang Green Enterprise 鈥?Marketing Network Focus on the enterprise purpose of "Take gene engineering as orientation, Render service to human health", the company adheres to serving the Chinese market as the main body and supporting some foreign markets as the auxiliary. Jiuyuan Marketing cultivates a professional, dedicated and enterprising pharmaceutical service team, establishes a stable, credible and efficient pharmaceutical service network, and focuses on timely delivery of high-quality pharmaceutical products which are the crystallization of scientific research, quality control and production, to the patients in urgent need, and efficient operation for safe, effective and economic use. We have been pursuing to improve professional pharmaceutical service skills, expand the radiation capacity of pharmaceutical service network, and it is our constant pursuit to make Jiuyuan Pharmaceutical products and medical device to serve human health. Marketing network spreads over the country more than 30 provinces and cities. The industrial map continues to extend, and the company's products export to Asia, South America, Europe, Africa and many other countries. 鈥?Social Responsibility and Corporate Culture Social Responsibility "Take gene engineering as orientation, Render service to human health", is the prospect placed by Mr. Tan Jiazhen (C.C.Tan) on Jiuyuan, who was a leading Chinese scientist in genetics and famous biological scientist, and it is also the final goal of Jiuyuan. In the recent two decades, Jiuyuan has been making its contribution to social programs. Corporate Culture Jiuyuan takes "learning" culture as the core, leads enterprises to "respect talents, advocate learning, enhance innovation, and accelerate scientific research". With the help of multi-dimensional publicity carriers such as internal journal, WeChat official account, video news, and cultural activit1ies of the Communist Party, the company makes all efforts to promote the construction of corporate culture and build a learning and focused efficient team.China Rivaroxaban powder API website:http://www.jiuyuan-gene.com/