Search Results for “antibody” – Page 29 – media

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42

Shanghai, China, March 14, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics and was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and U.S. Food and Drug Administration (FDA). In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC) patients with disease progression on EGFR targeted therapies. Epidermal growth factor receptor (EGFR) belongs to the receptor tyrosine kinases family and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. Mutation or overexpression of EGFR is considered to be closely associated with the occurrence of various solid tumours ...
- Source: drugdu
- 85
- March 18, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 174
- March 18, 2024
SHANGHAI RAAS and Boehringer Ingelheim enter into a major collaboration to develop innovative drugs for hemophilia

SHANGHAI RAAS and Boehringer Ingelheim, one of the world’s leading biopharmaceutical companies, announced today that they have entered into a major collaboration: Boehringer Ingelheim BioPharmaceuticals (China) Ltd. will provide process transfer and clinical manufacturing services for SHANGHAI RAAS’s innovative hemophilia drug, SR604 injection. Boehringer Ingelheim China Biopharmaceutical (“Boehringer Ingelheim China Biopharmaceutical”) will provide process transfer and clinical manufacturing services for SR604 injection, an innovative hemophilia drug under Shanghai Lacey, which will be transformed into a high-quality end-product through the international first-class CDMO platform, helping Chinese innovations to go overseas to benefit patients worldwide. SR604 injection is a humanized monoclonal antibody that binds human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the State Drug Administration (SDA) has officially approved SR604 injection. Recently, the State Drug Administration formally approved an application for a clinical phase I trial of SR604 injection, to ...
- Source: drugdu
- 122
- March 18, 2024
Hengrui Medicine’s new “PARP inhibitor” HRS-1167 combination therapy for advanced solid tumors received clinical approval

Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
- Source: drugdu
- 167
- March 15, 2024
BIO-THERA’s BAT8008 (ADC-Trop2) for injection in combination with BAT1308 (PD-1) for the treatment of advanced solid tumors was approved for Phase IB-II clinical trial.

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approved the application for Phase IB-II clinical trial of BAT8008 for injection in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an antibody-drug coupling (ADC) developed by BIO-THERA to target Trop2, a tumor-associated calcium signal transducer (TACSTHERA), to be developed for the treatment of solid tumors. Trop-2 (Trophoblast cell-surface antigens 2, Trop2), a member of the tumor-associated calcium signal transducer (TACSTD) family of genes, is involved in the regulation of intracellular calcium concentration.Trop2 is not expressed or is lowly expressed in normal human tissues, but is highly expressed in a variety ...
- Source: drugdu
- 192
- March 15, 2024
The IND Application of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 Approved by NMPA

Shanghai, China, Mar 12th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for clinical trial of HLX6018，a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases. Currently, no mAb targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial lung disease with unknown etiology, and was ...
- Source: drugdu
- 177
- March 14, 2024
2024 AACR Outlook | Chiatai Tianqing’s Innovative Drug Anrotinib, TQB2916 (CD40 Agonist) Together with 5 Studies to be Presented on the International Stage

The annual meeting of the American Association for Cancer Research (AACR) will be held on April 5-10, 2024, local time in San Diego, USA. As one of the world’s most influential academic events in the field of oncology, the AACR Annual Meeting focuses on all aspects of oncology research and innovation, and releases cutting-edge research results in the field of global oncology. Recently, AACR officially released the information of selected studies, and five studies of two innovative drugs, namely, Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor) and TQB2916 (CD40 agonist) from Chiatai Tianqing Pharmaceutical Group, have been selected. Clinical Studies ALTER-G-001 A Multicohort, Multicenter, Phase II Study – Cohort C Results Update: Anlotinib in Combination with Chemotherapy for First-Line Treatment of Digestive Tract Tumors with Unresectable Liver Metastases CT213/13 – Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, ...
- Source: drugdu
- 181
- March 14, 2024
FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

Davy James Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia. The FDA has approved an expanded indication for Regeneron’s PCSK9 inhibitor Praluent (alirocumab) to include patients 8 years of age and older for the reduction of low-density lipoprotein cholesterol (LDL-C) in those with heterozygous familial hypercholesterolemia (HeFH).1 In clinical trials, the fully human monoclonal antibody, which binds and inhibits to circulating PCSK9, has been found to lower LDL-C in patients with hyperlipidemia either as a monotherapy or combined with other lipid-lowering therapies (LLTs).2 “Many children with (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies,” said Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, in a press release. “But for those children whose LDL-C remains dangerously high, this approval is an important milestone as it gives these children ...
- Source: drugdu
- 172
- March 13, 2024
Biokin Pharmaceutical has successfully completed the initial payment of USD 800 million under the development and commercialization license agreement with Bristol Myers Squibb for BL-B01D1

As of March 7, 2024, Biokin Pharmaceutical has received an initial payment of USD 800 million from Bristol Myers Squibb under the development and commercialization license agreement for BL-B01D1. Agreement Signing and EffectivenessOn December 11, 2023, SystImmune, Inc., a wholly-owned subsidiary of Biokin Pharmaceutical, entered into an exclusive licensing and collaboration agreement (hereinafter referred to as the “Collaboration Agreement”) with Bristol Myers Squibb (hereinafter referred to as “BMS”, NYSE ticker: BMY) pertaining to the BL-B01D1 (EGFR×HER3 bispecific ADC) project. Under the terms of the Agreement, the Parties will jointly pursue the development and commercialization of BL-B01D1 in the United States. SystImmune will exclusively be responsible for the development, commercialization, and production of BL-B01D1 within Chinese mainland through its affiliated entities, including manufacturing some drugs for supply to regions outside of Chinese mainland. Conversely, BMS will retain exclusive right to develop and commercialize BL-B01D1 in all other regions globally. The Collaboration ...
- Source: drugdu
- 96
- March 13, 2024
FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
- Source: drugdu
- 134
- March 12, 2024

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