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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
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- March 18, 2024
Fosun Pharma’s Schizophrenia Drug Anxinqi® Approved for Marketing

On March 13, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd, and its subsidiary, Jinzhou Avanc Pharma Limited Liability Company (hereinafter referred to as Avanc Pharma), jointly developed the application for registration of Aripiprazole Oral Solution (trade name: Anxinqi®). The application for marketing registration of aripiprazole oral solution (trade name: Anxinqi®) jointly developed by Aohong Pharmaceutical Co. The drug is used for the treatment of schizophrenia in adolescents and adults aged 13 to 17 years old. Compared with other psychotropic drugs, it has the advantages of less side effects, significant efficacy, low relapse rate, etc. It is suitable for the long-term treatment of schizophrenia patients with a full course of disease, and it is the first-line anti-schizophrenia drug recommended by many domestic and foreign guidelines. Compared with oral solid preparation, oral solution has good fluidity, easy to take, precise and convenient dosage ...
- Source: drugdu
- 182
- 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
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- March 18, 2024
2024 AACR | Latest research results on garsorasib (D-1553 tablets, KRAS G12C inhibitor) to be announced soon

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. At the meeting, Yifang Bio will present the latest results from the Phase II clinical trial of garsorasib (D-1553) in patients with non-small cell lung cancer (NSCLC) with KRAS G12C mutation. This will mark the study’s (NCT05383898) appearance at a prestigious international academic conference following the World Conference on Lung Cancer (WCLC) 2022. About Garsorasib KRAS mutations are widespread in several highly lethal cancer types, with KRAS G12C being a specific KRAS mutation that accounts for approximately 44% of all KRAS mutations.KRAS G12C mutations are more common in lung, colorectal, pancreatic, and bile duct cancers. According to Frost & Sullivan, from 2016 to 2020, the number of incidence of major KRAS G12C-mutated cancers in China increased from 38,000 to 43,000, and is expected to reach 58,000 ...
- Source: drugdu
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- March 18, 2024
Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC

Recently, an Innovation Passport designation has been awarded to serplulimab, Henlius’ self-developed anti-PD-1 mAb (trade name in China: HANSIZHUANG), for the treatment of extensive stage small cell lung cancer (ES-SCLC) by the U.K. Innovative Licensing and Access Pathway Steering Group including the Medicines & Healthcare products Regulatory Agency (MHRA). This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. ILAP steering group consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). It was launched by the MHRA in order to accelerate the development and access to promising medicines. The designation is open to medicinal product that developed for life-threatening or seriously debilitating condition and meet ...
- Source: drugdu
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- 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
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- March 18, 2024
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics. Traditionally, exosomes are isolated through ultrasound centrifugation, a process that requires eight hours or more, requires large sample volumes, and often harms the integrity of these delicate structures. Alternative methods also present challenges, including low purity and yield. Now, researchers have devised a diagnostic technique that employs sound waves to spin a single water droplet at speeds reaching 6,000 revolutions per minute, thereby facilitating the separation of tiny biological particles for exosome-based diagnostics. This novel approach involves a lightweight disk atop the spinning droplet and featuring etched channels that incorporate star-shaped nanoparticles designed for the label-free identification of exosomes. This method surpasses traditional techniques in efficiency, requiring less time and smaller sample volumes, and minimizes damage to the exosomes. It represents a significant ...
- Source: drugdu
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- March 16, 2024
Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment

Melioidosis, a neglected tropical disease, is believed to affect around 165,000 individuals globally each year, with approximately 89,000 succumbing to it. This illness is caused by the bacterium Burkholderia pseudomallei, which thrives in the soil and water of tropical and subtropical areas, gaining entry into humans through skin cuts, consumption, or inhalation. Diagnosing melioidosis poses challenges due to its varying symptoms ranging from localized infections and pneumonia to severe septicemia or prolonged chronic conditions. The disease’s tendency to predominantly affect isolated rural communities contributes to its significant underreporting. Diagnosis traditionally depends on culturing bacterial specimens, a process extending over three to four days. Meanwhile, a large percentage of patients with melioidosis succumb to the disease, often within the initial 24 to 48 hours of hospital admission, while waiting for a diagnosis. Although no vaccine exists for melioidosis, it can be effectively managed with specific intravenous antibiotics if identified promptly. However, ...
- Source: drugdu
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- March 16, 2024
New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

Don Tracy, Associate Editor Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.A 2014 recommendation by the Advisory Committee on Immunization Practices (ACIP) for adults aged 65 years and over to receive Prevnar 13 was followed by Pfizer initiating a high-profile advertisement campaign for the vaccinations. During this time, Medicare and private insurance companies began covering the vaccine as well. According to a new study published in the Journal of Policy Analysis and Management, over the next five years, this resulted in a 10% increase in vaccination among seniors and a corresponding $1 billion annual increase in Prevnar 13 sales. According to the authors of the study, government vaccine recommendations may offer substantial value to pharmaceutical manufacturers, further implying that direct-to-consumer (DTC) advertising can lead to successfully achieving public health goals ...
- Source: drugdu
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- March 16, 2024
Schizophrenia Trial Failure Ends Acadia’s Efforts to Expand Use of Its Flagship Drug

With pimavanserin’s Phase 3 failure in schizophrenia, Acadia Pharmaceuticals said it will no longer run clinical trials for the drug, whose lone approval is for treating psychosis from Parkinson’s disease. The FDA previously rebuffed regulatory submissions for the drug in dementia and Alzheimer’s disease. By FRANK VINLUAN An Acadia Pharmaceuticals drug that’s already approved for treating psychosis in Parkinson’s disease patients could not beat a placebo in a pivotal schizophrenia study, spelling the end of efforts to develop a medication the company once envisioned as having potential applications across a range of neurological disorders. The clinical trial failure announced Tuesday evaluated the drug, pimavanserin, as a treatment for negative symptoms of schizophrenia. The main goal was to show a change in score according to an assessment used to measure the disease’s symptoms. According to the preliminary results, the pimavanserin arm achieved a numerical change in score that was similar to ...
- Source: drugdu
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- March 16, 2024

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