Our History
Established in 2019, as a joint venture by Genovior Biotech Corporation and New Hope Group(a Fortune 500 company), Fujian Genohope Biotech Ltd. is a leading comprehensive Contract Injectable Drug Manufacturing Organization in China. The company is committed to create an affordable high value medicine environment worldly. Genohope mainly specialize on high valuable Diabetes& Obesity and Oncology products. Not only High Potency Active Pharmaceutical Ingredients(HP APIs) but also various Injectable Finished Dosage Forms(FDF） can be customized,developed and manufactured.
With over 220 talents and 20-year-experience core Research and Development among them, Genohope has an outstanding privilege of efficient and effective output. So far, the business has achieved a dozen of product portfolio and some of them have been commercialized. The product portfolio includes many more high potency medicines Liraglutide, Semaglutide, Fulvestrant, Carfilzomib, Ranibizumab and Ponatinib than Azacitidine, Bortezomib, Bumetanide, Landiolol , Telipressin, Leuprolide Mesylate and Pemetrexed Disodium as well. Moreover, Genohope is endeavoring to develop very new potential medicines adhered to human health and cost availability.
Covering 55 acres, 17 laboratories and over 12 production lines, Genohope makes itself possible to support continuously quality production. There are two Peptide API plants, two Oncology API Plants, two Biotech API Plants and two General API Plants.
As for Finished Dosage Form Plants, two are for Anticancer Preparation Plants and the other two are Multiple Function Plants.
Young as it is, Genohope has bridged many business partners domestically and worldly. In July 2023, as a key ingredient supplier, Genohope has been approved by FDA. In addition to FDA ,EMA and PMDA yearly inspection experience, the company has scheduled to be audited and approved by NMPA by the end of 2023. As an international firm, Genohope is stepping forwards to the other parts of the world.
Dedicating to be the first stop Injectable CDMO(Contract Drug Manufacturing Organization) in the globe, Genohope will consistently offer its first class service for high quality medicines and high cost performance.
Genohope Developing Timeline
Jan 2019 Genohope Setup
March 2020 Plant Facility Assembled
Feb 2021 Drug Manufactureing Certificate Adopted
March 2022 Initial Drug Registration Application
Oct 2022 Fulvestrant API in-site inspected by CDE
Feb 2023 Fulvestrant FDF in-site inspected by CDE
July 2023 Sterile Water inspected and appoved by FDA
Our Factory
Finished Dosage Form Plant
1 Leophilized powder/Water Injection Plant
- Specifications: 2ml, 10ml, 20ml, 30ml, 50ml or customized vials.
- Maximum batch of leophilized powder: 200,000 bottles/batch.
- Filling Volume: 0.2ml to 30ml or customer demand filling viscosity liquid medicine
- Annual Production Capacity: 90 million pieces (water injection).
- Remarks: Vials of water needles can be produced, and the production equipment complies with OEB5.
2 Prefilled Injection Plant
- Specifications: 1ml, 2.25ml, 3.0ml, 5.0ml or others can be customized.
- Filling Volume: 0.2ml to 5.0mml or filling viscosity liquid according to customer requirements
- Syringe Injection and Rubber Stopper: can be provided by the customer or entrusted by Genohope.
- Annual Production Capacity: 30 million pieces.
- Remarks: Production equipment complies with OEB4 (upgradeable).
3 Prefilled Cartridge Injection Plant
- Specifications: 3.0ml or others can be customized.
- Filling Volume: 0.2ml to 3.0ml or filling viscosity liquid according to customer requirements.
- Syringe Injection and Rubber Stopper: can be provided by the customer or entrusted by Genohope.
- Annual Production Capacity: 30 million pieces.
- Remarks: Cartridges and injection pens can be assembled according to customer needs, and the production equipment meets OEB4 (upgradeable).
Active Pharmaceutical Ingredient Plant
1 Oncology Plant
At present, the anti-cancer API synthesis workshop can produce 3 kg of API per batch. Its process temperature ranges from minus 20 degrees to high temperature of 150 degrees. The size of the equipment used is from 50L glass reactor to 750L stainless steel reactor. The purification process adopts crystallization and column purification. In terms of filtration, centrifuges, positive pressure plate filters and multi-layer plate filters are used. The drying equipment uses a heating oven and a double-cone rotary vacuum dryer. Besides, thhere is also an isolator
2 Peptide Plant
At present, the polypeptide API synthesis workshop can produce 300 g API per batch. Its solid phase synthesis reactor has 3L and 10L. In addition to the positive pressure plate filter, the filtration equipment is also equipped with a low-temperature high-speed centrifuge to make the separation of macromolecules better. The subsequent purification equipment is carried out using MPLC (Medium Pressure Preparative Chromatography). The purified liquid is concentrated through the TFF (Tangential Flow Filtration Equipment) system, and then freeze-dried. The area of the freeze dryer is 2 m2.
Additionally, 5-10kg per batch new production line is under installation.
Expectedly, the new plant will be finished by the end of 2023.
3 Bio Plant
The biotechnology plant has microbial culture equipment, protein purification equipment, ultrafiltration equipment and freeze-drying equipment, etc. Its microbial fermentation scale ranges from 7 L to 500 L, and the purification equipment is mainly equipped with AKTAready (liquid chromatography system), MPLC (medium pressure preparative chromatography) and chromatography columns. The ultrafiltration equipment is TFF (Tangential Flow Filtration Equipment). There is also a 2 m2 freeze dryer.
Hot Productsr
|
Classification |
Product Name |
API Availability |
FDF Availability |
|
Peptide |
Liraglutide |
YES |
N/A |
|
Semaglutide |
YES |
N/A |
|
|
Terlipressin |
YES |
YES |
|
|
Leuprolide Mesylate |
YES |
YES |
|
|
Oncology |
Azacitidine |
YES |
YES |
|
Bortezomib |
YES |
YES |
|
|
Bendamustin |
YES |
YES |
|
|
Carfilzomib |
YES |
YES |
|
|
Fulvestrant |
YES |
YES |
|
|
Pemetrexed Disodium |
YES |
YES |
|
|
Others |
Bumetanide |
YES |
N/A |
|
Landiolol |
YES |
N/A |
|
|
Ranibizumab |
YES |
N/A |
Production Market
Main Marketing Area: North America, EU, Middle East, South-east Area and China Main-land.
Product Application
Genohope mainly focus on diabetes& obesity and oncology.
Our Service
Working Time
Pre-sale
Monday- Friday
8:00am-17:00pm (Beijing Time）
After- sale
7*24 hours