-
-
- 2021-04-12
Henlius News | Supplementary Application of Han Da Yuan® for New Indication for Uveitis Formally Approved
On April 12, 2021, Henlius (2696.HK) announced that the supplementary application (sNDA) of its independently developed Han Da Yuan® (HLX03, adalimumab injection) for the treatment of non-infectious intermediate, posterior and total uveitis in adults had recently been officially approved by the National Medical Products Administration (NMPA). This is the fourth approved indication of Han Da Yuan® in China following rheumatoid arthritis, ankylosing spondylitis and psoriasis.
-
-
-
- 2021-03-22
Approval From US FDA — Henlius Bevacizumab Approved For Clinical Trials Of Ophthalmic Indication
Shanghai, China, March 19th, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application of HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody ophthalmic injection jointly developed by the Company and Essex has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (wAMD).
-
-
-
- 2021-03-18
Fosun Pharma: Approval for Clinical Trial of Small Molecule Innovator Drug for the Treatment of Advanced Solid Tumors
[March 18, 2021 in Shanghai, China] Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH; 02196.HK) announced that its subsidiary YaoPharma Co., Ltd. ("YaoPharma") had recently received the approval from the NMPA regarding the clinical trial for the YP01001 capsules (the “Investigational New Drug”) for the treatment of advanced solid tumors.
-
-
-
- 2021-02-25
BioNTech and Fosun Pharma Receive Special Import Authorization in Macau for COVID-19 mRNA Vaccine
Macau plans to purchase a total of 400,000 doses (including the 105,000 doses granted the Special Import Authorization) COVID-19 mRNA vaccine BNT162b2 for the local COVID-19 vaccination program.
-
-
-
- 2021-02-18
Wanbang Biopharma Ticagrelor Tablets and Apixaban Tablets Approved for Marketing
Recently, Jiangsu Wanbang Biopharmaceuticals Co., Ltd. ("Wanbang Biopharma") received marketing approval for Ticagrelor Tablets (Wansujie®) and Apixaban Tablets (Keyue®) from NMPA. The marketing of these two products will help solve more anti-thrombotic needs in clinical practice, benefit more patients, and enrich the product pipeline layout and enhance the product power of Wanbang Biopharma.
-
-
-
- 2021-02-05
Developments in the Field of Diabetes: Wanbang Biopharma Empagliflozin Approved for Marketing
On February 2, 2021, Wanbang Biopharma's Empagliflozin Tablets, the new generation oral sodium-glucose co-transporter-2 (SGLT2) inhibitor, was approved by NMPA (Approval No.: GYZZ H20213115) for glucose control in patients with type 2 diabetes alone or in combination with metformin or metformin and sulfonylureas.
-
-
-
- 2021-02-03
New Application of Henlius Bevacizumab — Ophthalmic Indication Receives Clinical Trial Approval In Australia
Shanghai, China, Jan, 29th, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of clinical trial for HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody ophthalmic injection, for the treatment of wet age-related macular degeneration (wAMD) has been approved by the Therapeutic Goods Administration, Australia. The Phase 3 clinical study of the project in Australia is intended to be initiated in the near future.
-
-
-
- 2021-01-25
BioNTech and Fosun Pharma Receive Authorization for Emergency Use of COVID-19 Vaccine in Hong Kong
“We are excited and encouraged that COMIRNATY® has been authorized to emergency use in Hong Kong. This is an important milestone in the joint efforts of BioNTech and Fosun Pharma to achieve vaccine accessibility globally.
-
-
-
- 2021-01-15
Henlius Reaches Exclusive License Agreement with Chiome for Antibodies Targeting Human TROP2
TROP2 (Trophoblast cell-surface antigen 2) is overexpressed in triple-negative breast cancer, non-small cell lung cancer, urothelial cancer and several other types of solid tumours, potentially to become a druggable target with a broad coverage of different types of tumours in various drug modalities including antibody-drug conjugates (ADC), bispecific antibodies and combination therapies.
-