2018
1. AnkeBio’s two newly declared indications of Recombinant Human Growth Hormone for Injection, "Noonan Syndrome" and "Children with Shox Gene Deficiency but without GHD", were accepted by the National Medical Products Administration.
2. AnkeBio officially launched the Phase I clinical trial for the Recombinant Anti-VEGF humanized monoclonal antibody injection.
3. Five newly declared indications of Recombinant Human Growth Hormone for Injection by AnkeBio were accepted by CFDA, namely: Chronic Renal Insufficiency before Kidney Transplantation (CKD), Turner syndrome (TS), Achondroplasia (ACh), Prader Willi Syndrome (PWS) and Short Bowel Syndrome (SBS).
4. AnkeBio’s AK-3008 injection Phase III Clinical Investigator Meeting was successfully held in Hefei. AK-3008, as a monoclonal antibody drug technology of AnkeBio, will be launched its clinical research with Avastin as the controlled drug in accordance with the Guiding Principles for the Development and Evaluation of Biosimilar Drugs according to the requirements of clinical approval.
5. AnkeBio has become one of the enterprise technology centers recognized by the state in the biomedical industry.
6. On November 13rd, 2018, the groundbreaking ceremony of antibody and protein drug production base project in North District of AnkeBio was grandly held.
7. AnkeBio was rated as a Demonstration Enterprise of Technological Innovation in Anhui Province in 2018.
2019
1. AnkeBio was selected into the list of "China's most influential pharmaceutical enterprises" and "China's pharmaceutical industry".
2. AnkeBio’s Recombinant Anti-PD1 Humanized Monoclonal Antibody Injection was approved by the National Medical Products Administration for clinical trials.
3. On June 10th, 2019, AnkeBio’s registration application of Recombinant Human Growth Hormone Injection, which attracted great attentions from investors, was approved by National Medical Products Administration. And after a lapse of 3 days, AnkeBio received the Drug Production and Registration Approval License issued by the National Medical Products Administration.
4. AnkeBio was awarded the National Technological Innovation Demonstration Enterprise in 2019.
5. AnkeBio was selected as one of the top 10 most valuable Chinese pharmaceutical listed companies in 2019.
2020
1. Recombinant Human Growth Hormone for Injection (trade name: ANSOMONE®), the key product of AnkeBio, was approved the Drug Registration Approval License issued by the National Medical Products Administration. And it is agreed that two new indications are added for this product on the basis of the original ones, which include the short stature in children caused by achondroplasia (ACH) and short bowel syndrome (SBS) in adults receiving nutritional support.
2. The clinical application of Recombinant Anti-HER2 Humanized HuA21 monoclonal antibody, a product of one of the subsidiaries of AnkeBio, was accepted.
2021
1. The marketing authorization application of AnkeBio’s “Trastuzumab for Injection” was accepted by the National Medical Products Administrtaion(NMPA), and it is the second domestic Trastuzumab biosimilar to be declared for marketing.
2. The indication for the treatment of idiopathic short stature (ISS), declared by AnkeBio for the product of Human Growth Hormone for Injection (trade name: ANSOMONE®), was approved for marketing, which is the first product approved for marketing for this kind of indication in China.
