SHE:300009

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China Accepts Anke Biotech's Clinical Trial Application for Tumor Drug

Anhui Anke Biotechnology (Group) (SHE:300009) has won approval from China's National Medical Products Administration (NMPA) to carry out clinical trials for its AK2405 drug for injection, according to a Monday filing with the Shenzhen bourse.The injection is a HER2-targeting antibody-drug conjugate (ADC), which has an antibody component that specifically binds to the target antigen on the surface of tumor cells.The product is classified under Registration Category 1 for therapeutic biological products and is used to treat advanced malignant solid tumors.The company said preclinical studies showed high specificity and anti-tumor activity.

SHE:300009

Asia49d ago

Anke Biotechnology Obtains European Certificate for Octreotide API

Anhui Anke Biotechnology (Group) (SHE:300009) subsidiary Shanghai Suhao Yiming Pharmaceutical received a European Pharmacopoeia certificate of suitability (CEP) for its octreotide active pharmaceutical ingredient, according to an after-hours filing on Monday with the Shenzhen Stock Exchange.Octreotide is used as a growth hormone inhibitor in the emergency treatment of acromegaly. It is also used to treat esophageal-gastric variceal bleeding associated with liver cirrhosis, Anke said in its filing.Shares rose 1% during afternoon trading on Tuesday.

SHE:300009

Asia54d ago

Anke Biotech Gets Nod to Market Terlipressin Acetate API

Anhui Anke Biotechnology (SHE:300009), through a unit, received approval from China's National Medical Products Administration for the marketing of an active pharmaceutical ingredient for terlipressin acetate, according to a Wednesday disclosure on the Shenzhen bourse.The drug is used for the treatment of gastrointestinal and genitourinary bleeding, postoperative bleeding, hepatorenal syndrome, refractory (catecholamine-resistant) shock, and can be used in gynecological surgery.

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