Launch of New Product-Pegneugen (Telpegfilgrastim Injection)

Launch of New Product

Xiamen, China, July 1, 2023/--Xiamen Amoytop Biotech Co., Ltd. (referred to as Amoytop Biotech hereinafter) today  announced that Pegneugen^® (Telpegfilgrastim Injection) has been approved by National Medical Products Administration  (NMPA) and is available for marketing.

On June 30, 2023, Telpegfilgrastim Injection (Trade name: Pegneugen) of Amoytop Biotech is  approved for marketing by China NMPA. This drug is indicated to decrease the incidence of infection,  as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving  myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile  neutropenia.

Pegneugen^® is a Y-shaped polyethylene glycol (PEG) modified human granulocyte colony-stimulating  factor (rhG-CSF), which stimulates bone marrow hematopoietic stem cells to differentiate into  granulocytes, promotes the proliferation, maturation, and release of granulocytes, and restores the  number of granulocytes in peripheral blood, to decrease the incidence of infection in tumor patients  after chemotherapy. The marketing of this drug provides more treatment options for patients.

Pegneugen^® is a long-acting human granulocyte colony-stimulating factor with independent  intellectual property rights, using a more stable and brand new PEG (40kD, Y-shape) to modify.  Compared with other PEG-rhG-CSF launched in China, Pegneugen^® has following advantages: 

●   Longer half-life; 

●   Lower administration dosage, only 1/3 of other launched PEG-rhG-CSF, i.e., at a fixed dose of 2mg or 33μg/kg; 

●   Efficiently and steadily increase leukocyte while reducing the potential risk of bone marrow  overmobilization.

The phase III clinical trials showed that: 

Single subcutaneous administration of Pegneugen^® at a fixed dose of 2mg or 33μg/kg according to  body weight 48 hours (±12 hours) after the end of each chemotherapy cycle have definite effects on  reducing the incidence and duration of grade 3 and grade 4 ANC (neutrophil absolute count) reduction,  preventing and reducing the occurrence of FN (neutropenic fever), and on reducing the incidence of  infection and the use of antibiotics that caused by ANC reduction. The incidence of adverse reactions  reported in clinical trials was less than 10%, and the overall safety and tolerability were good.  Compared with regular rhG-CSF, Pegneugen® has potential advantages in reducing the incidence of  various skeletal muscle and joint pain. 

The launch of Pegneugen® will provide a more efficient and cost-effective option for tumor patients  with chemotherapy/radiotherapy-related neutropenia.