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AstraZeneca and Amgen’s Tezspire Shows Positive Results in Phase III Study
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AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) have jointly announced positive results from the Phase III WAYPOINT study for their co-developed drug Tezspire (tezepelumab). Tezspire is a thymic stromal lymphopoietin (TSLP) – targeted monoclonal antibody (mAb) that has been approved for severe asthma in over 60 countries worldwide. Study ResultsThe…
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CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G…
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CSPC Pharmaceutical’s Sirolimus Receives BTD for Malignant PEComa Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its sirolimus (albumin-bound) as a monotherapy for malignant perivascular epithelioid cell tumor (PEComa). Drug ProfileSirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor.…
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Bayer’s BlueRock Therapeutics Gets Fast Track for OpCT-001 Therapy
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German pharmaceutical giant Bayer (ETR: BAYN) and its wholly owned subsidiary BlueRock Therapeutics LP announced that they have received Fast Track Designation from the US Food and Drug Administration (FDA) for OpCT-001. The investigational therapy, derived from induced pluripotent stem cells (iPSC), is intended for the treatment of primary photoreceptor…
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Chipscreen Biosciences’ CS12088 Gets NMPA Clearance for Hepatitis B Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that the National Medical Products Administration (NMPA) has granted clearance to conduct a study of its investigational drug CS12088 in adult patients with chronic hepatitis B. Drug Mechanism and Preclinical DataCS12088 is an HBV nucleocapsid assembly regulator that interferes with the…
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Hengrui Pharmaceuticals Gets NMPA Green Light for SHR-A2009 Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II clinical study for its drug candidate SHR-A2009. The study will assess the safety, tolerability, and efficacy of SHR-A2009 as a treatment for advanced solid tumors in…
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Akeso Inc. Completes Patient Enrollment for AK138D1 Phase I Study
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of its AK138D1 in advanced malignant tumors in Australia. Drug ProfileAK138D1, an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3), features…
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CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
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Adagene Starts Phase II Trial of Muzastotug for Colorectal Cancer
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China-based Adagene Inc. (NASDAQ: ADAG) announced the initiation of an Investigator-Initiated (IIT) Phase II trial for muzastotug (ADG126) as a neoadjuvant therapy for patients with stage II or stage III colorectal cancer. Drug ProfileMuzastotug is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells…
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Shanghai Moyang Biotech’s Aphranel CC Needle Wins NMPA Approval
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China-based Shanghai Moyang Biotechnology Co., Ltd, an innovation-focused company in nanomedical biomaterials and Class III absorbable implants, announced it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its Aphranel CC needle. The high-end medical aesthetics product is used for subcutaneous injection of…
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Huadong Medicine’s ADC HDM2005 Granted FDA Orphan Drug Designation for MCL
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL). Drug Mechanism and Preclinical ResultsPreclinical studies have shown that after HDM2005 enters the…
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AstraZeneca’s Camizestrant Shows Promise in SERENA-6 Breast Cancer Study
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) announced positive interim analysis results from the Phase III SERENA-6 study for its camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Study Details and ResultsThe study evaluated switching to camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor…
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Bayer’s Gadoquatrane Shows Positive Results in Phase III QUANTI CNS Study
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German pharmaceutical giant Bayer (ETR: BAYN) announced positive results from the Phase III QUANTI CNS study for its gadoquatrane, a gadolinium-based contrast agent (GBCA), in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced magnetic resonance imaging (MRI). Study Details and ResultsIn the trials, gadoquatrane was…
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Precigen’s RRP Therapy PRGN-2012 Gets FDA Review
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US-based cell and gene therapy (CGT) specialist Precigen, Inc. (NASDAQ: PGEN) announced that the US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for its zopapogene imadenovec (PRGN-2012) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The agency is expected to act on the…
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InnoCare Pharma’s Orelabrutinib Shows Efficacy in RRMS at ACTRIMS Forum
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Beijing-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the presentation of Phase II study results for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in relapsing-remitting multiple sclerosis (RRMS) at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. Study HighlightsThe data demonstrated significant efficacy of…
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Jiangsu Hengrui’s HRS-1301 Receives NMPA Approval for Hyperlipidemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its Category 1 chemical drug HRS-1301 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of hyperlipidemia. Clinical Approval DetailsThe approval marks a significant milestone for HRS-1301, a novel drug designed to address hyperlipidemia.…
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Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml:…
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Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels…
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J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics. Drug ProfileTremfya, an interleukin-23 monoclonal antibody, was…
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Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
