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 has been approved in China for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
Envafolimab was included for the first time into 3 CSCO guidelines:
1. CSCO Guidelines for Gastric Cancer 2022 Version (Class I recommendation, Level 2A evidence)
2. CSCO Guidelines for Colorectal Cancer 2022 Version (Class II recommendation, Level 2A evidence)
3. CSCO Guidelines for Clinical Application of Immune Checkpoint Inhibitors 2022 Version (Class I recommendation, Level 2A evidence)
The new usage and dosage scheme of "300mg administered every two weeks" was approved by the National Medical Products Administration (NMPA).
Envafolimab was included into CSCO guidlines 2022 version for endometrial cancer and cervical carcinomaI. It is recommended for the second-line treatment of recurrent and metastatic endometrial cancer and recurrent and metastatic cervical cancer with microsatellite instability-high / different mismatch repair function defects (MSI-H / dMMR).
3D185 was certified as an orphan drug for the treatment of biliary tract cancer.
The results of three Phase I clinical trials of Envafolimab® (Subcutaneous Injection PD-L1) conducted in China, the United States, and Japan for the treatment of patients with advanced refractory solid tumors were obtained.
The data update and subgroup analysis of subjects with advanced solid tumors of MSI-H/dMMR treated with Envafolimab® (Subcutaneous Injection PD-L1) after a follow-up of 26.8 months were reported at the CSCO Conference
The Company was officially listed on HKEX, with a company abbreviation of 3D Medicines and a company code of 01244.HK
An official notice of IND from the FDA was obtained for Envafolimab® (Subcutaneous Injection PD-L1) to conduct the Phase II clinical trial in the treatment of advanced solid tumors of dMMR
Announced the Annual Report of 2022. The first commerical procuct Envafolimab have generated revenues of RMB 567.4 million.
Corporation with Yisi(翊斯生物),research and develop the new generation therapy of mRNA cancer vaccine
The Phase III clinical study of envafolimab neoadjuvant/adjuvant therapy for patients with non-small cell lung cancer has been licensed by the National Medical Products Administration
Company was recognized as the second batch of “professional、proficient、Special、New"(专精特新) small and medium-sized enterprises in Shanghai in 2023
Announced the Annual Report of 2023.
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 has been approved in China for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
Envafolimab was included for the first time into 3 CSCO guidelines:
1. CSCO Guidelines for Gastric Cancer 2022 Version (Class I recommendation, Level 2A evidence)
2. CSCO Guidelines for Colorectal Cancer 2022 Version (Class II recommendation, Level 2A evidence)
3. CSCO Guidelines for Clinical Application of Immune Checkpoint Inhibitors 2022 Version (Class I recommendation, Level 2A evidence)
The new usage and dosage scheme of "300mg administered every two weeks" was approved by the National Medical Products Administration (NMPA).
Envafolimab was included into CSCO guidlines 2022 version for endometrial cancer and cervical carcinomaI. It is recommended for the second-line treatment of recurrent and metastatic endometrial cancer and recurrent and metastatic cervical cancer with microsatellite instability-high / different mismatch repair function defects (MSI-H / dMMR).
3D185 was certified as an orphan drug for the treatment of biliary tract cancer.
The results of three Phase I clinical trials of Envafolimab® (Subcutaneous Injection PD-L1) conducted in China, the United States, and Japan for the treatment of patients with advanced refractory solid tumors were obtained.
The data update and subgroup analysis of subjects with advanced solid tumors of MSI-H/dMMR treated with Envafolimab® (Subcutaneous Injection PD-L1) after a follow-up of 26.8 months were reported at the CSCO Conference
The Company was officially listed on HKEX, with a company abbreviation of 3D Medicines and a company code of 01244.HK
An official notice of IND from the FDA was obtained for Envafolimab® (Subcutaneous Injection PD-L1) to conduct the Phase II clinical trial in the treatment of advanced solid tumors of dMMR
Announced the Annual Report of 2022. The first commerical procuct Envafolimab have generated revenues of RMB 567.4 million.
Corporation with Yisi(翊斯生物),research and develop the new generation therapy of mRNA cancer vaccine
The Phase III clinical study of envafolimab neoadjuvant/adjuvant therapy for patients with non-small cell lung cancer has been licensed by the National Medical Products Administration
Company was recognized as the second batch of “professional、proficient、Special、New"(专精特新) small and medium-sized enterprises in Shanghai in 2023
Announced the Annual Report of 2023.