live longer and better.
We began engaged in drug discovery and development business through 3DMed Beijing, one of our principal operating subsidiaries.
- In February 2016, we entered into an agreement with the Alphamab Group in relation to, among others, co-development and exclusive commercialization rights of envafolimab (KN035) in oncological indications.
- In December 2016, we received IND approval from NMPA for envafolimab in December.
- In February 2017, we launched the first-in-human Phase I trial of envafolimab in the U.S.
- In March 2017, we launched Phase I trial of envafolimab in China.
- In October 2017, we launched Phase I trial of envafolimab in Japan.
- In November 2017, we made a global PCT patent application for 3D011.
- In April 2018, we launched a randomized Phase III trial in advanced biliary tract cancer (BTC) in the PRC for envafolimab.
- In August 2018, we launched a pivotal Phase II trial of envafolimab in previously treated advanced MSI-H/dMMR cancers.
- In September 2018, we obtained global rights to develop, manufacture, import, use, register, commercialize, and grant sub-license for our development of 3D185 from the Haihe Biopharma Group for treatment of tumor and pulmonary fibrosis globally.
- In December 2018, we launched the first-in-human Phase I trial of 3D185.
- In September 2019, we received IND approval from FDA for 3D185.
- In October 2019, 3DMed Beijing received the High-tech Enterprise Certificate(高新技術企業證書).
- In December 2019, we entered into a collaboration and clinical trial agreement with the Alphamab Group and TRACON for clinical development and commercialization of envafolimab for the treatment of sarcoma in the U.S., Canada, Mexico and each of their dependent territories.
We received orphan drug designation from FDA for envafolimab for the treatment of advanced BTC.
We entered into a tripartite collaboration agreement with the Alphamab Group and the Simcere Group for the manufacturing, promotion and distribution of envafolimab in the PRC.
We licensed-in the development, manufacturing and commercialization rights of 3D1001 and 3D1002 in the PRC from the Haihe Biopharma Group.
We entered into a collaboration and license agreement with Aravive Inc. for an exclusive license to develop and commercialize products that contain 3D229 as the sole drug substance, for the diagnosis, treatment or prevention of human oncological diseases, in mainland China, Taiwan region, Hong Kong and Macau.
- We obtained the BLA acceptance from NMPA for envafolimab in the treatment of advanced solid tumors with MSI-H/dMMR.
- We entered into a license agreement with SELLAS Life Sciences Group, Inc., a company listed on Nasdaq, and its subsidiary (collectively “SELLAS”) for license of certain intellectual property owned or controlled by SELLAS for the purpose of developing, manufacturing and commercializing our 3D189 and 3D059 for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan region.
- We entered into a license agreement with Y-Biologics with respect to license of 3D057 (also known as YBL-013), a T cell bi-specific engager, pursuant to which we will obtain the exclusive right to develop, manufacture and commercialize 3D057 in therapeutic, palliative, prophylactic and diagnostic applications for all therapeutic areas based on Y-Biologics’ Antibody Like Cell Engager (ALiCE) platform technology in China, Hong Kong, Macau and Taiwan region.
- We received IND approval for 3D011 from NMPA.
- Our envafolimab was publicly announced to be accepted for priority review by NMPA.
- We filed the IND for 3D229 in China.
- We entered into a license agreement with ImmuneOncia Therapeutics, Inc. for an exclusive license for the development, manufacturing and commercialization of 3D197 (also known as IMC-002) in mainland China, Hong Kong, Macau and Taiwan region in respect of oncology indications.
We filed the IND for 3D229 for a Phase III clinical trial in patients with PROC in China to participate in the MRCT.
- We received approval from NMPA to initiate clinical trial for 3D229.
- The first-in-human study of envafolimab was published on the Oncologist.
The Phase II pivotal clinical trial result of our envafolimab was published on the Journal of Hematology & Oncology.
Envafolimab injection approved for marketing (China)
We began engaged in drug discovery and development business through 3DMed Beijing, one of our principal operating subsidiaries.
- In February 2016, we entered into an agreement with the Alphamab Group in relation to, among others, co-development and exclusive commercialization rights of envafolimab (KN035) in oncological indications.
- In December 2016, we received IND approval from NMPA for envafolimab in December.
- In February 2017, we launched the first-in-human Phase I trial of envafolimab in the U.S.
- In March 2017, we launched Phase I trial of envafolimab in China.
- In October 2017, we launched Phase I trial of envafolimab in Japan.
- In November 2017, we made a global PCT patent application for 3D011.
- In April 2018, we launched a randomized Phase III trial in advanced biliary tract cancer (BTC) in the PRC for envafolimab.
- In August 2018, we launched a pivotal Phase II trial of envafolimab in previously treated advanced MSI-H/dMMR cancers.
- In September 2018, we obtained global rights to develop, manufacture, import, use, register, commercialize, and grant sub-license for our development of 3D185 from the Haihe Biopharma Group for treatment of tumor and pulmonary fibrosis globally.
- In December 2018, we launched the first-in-human Phase I trial of 3D185.
- In September 2019, we received IND approval from FDA for 3D185.
- In October 2019, 3DMed Beijing received the High-tech Enterprise Certificate(高新技術企業證書).
- In December 2019, we entered into a collaboration and clinical trial agreement with the Alphamab Group and TRACON for clinical development and commercialization of envafolimab for the treatment of sarcoma in the U.S., Canada, Mexico and each of their dependent territories.
We received orphan drug designation from FDA for envafolimab for the treatment of advanced BTC.
We entered into a tripartite collaboration agreement with the Alphamab Group and the Simcere Group for the manufacturing, promotion and distribution of envafolimab in the PRC.
We licensed-in the development, manufacturing and commercialization rights of 3D1001 and 3D1002 in the PRC from the Haihe Biopharma Group.
We entered into a collaboration and license agreement with Aravive Inc. for an exclusive license to develop and commercialize products that contain 3D229 as the sole drug substance, for the diagnosis, treatment or prevention of human oncological diseases, in mainland China, Taiwan region, Hong Kong and Macau.
- We obtained the BLA acceptance from NMPA for envafolimab in the treatment of advanced solid tumors with MSI-H/dMMR.
- We entered into a license agreement with SELLAS Life Sciences Group, Inc., a company listed on Nasdaq, and its subsidiary (collectively “SELLAS”) for license of certain intellectual property owned or controlled by SELLAS for the purpose of developing, manufacturing and commercializing our 3D189 and 3D059 for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan region.
- We entered into a license agreement with Y-Biologics with respect to license of 3D057 (also known as YBL-013), a T cell bi-specific engager, pursuant to which we will obtain the exclusive right to develop, manufacture and commercialize 3D057 in therapeutic, palliative, prophylactic and diagnostic applications for all therapeutic areas based on Y-Biologics’ Antibody Like Cell Engager (ALiCE) platform technology in China, Hong Kong, Macau and Taiwan region.
- We received IND approval for 3D011 from NMPA.
- Our envafolimab was publicly announced to be accepted for priority review by NMPA.
- We filed the IND for 3D229 in China.
- We entered into a license agreement with ImmuneOncia Therapeutics, Inc. for an exclusive license for the development, manufacturing and commercialization of 3D197 (also known as IMC-002) in mainland China, Hong Kong, Macau and Taiwan region in respect of oncology indications.
We filed the IND for 3D229 for a Phase III clinical trial in patients with PROC in China to participate in the MRCT.
- We received approval from NMPA to initiate clinical trial for 3D229.
- The first-in-human study of envafolimab was published on the Oncologist.
The Phase II pivotal clinical trial result of our envafolimab was published on the Journal of Hematology & Oncology.
Envafolimab injection approved for marketing (China)