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Tonghua Dongbao’s Tongboli Under GMP Inspection in Egypt
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced that the on-site Good Manufacturing Practice (GMP) inspection by the Ministry of Health of Egypt for its Tongboli, a biosimilar version of Novo Nordisk’s GLP-1 receptor agonist Victoza (liraglutide), is well underway in the country. Product BackgroundTongboli, the Victoza knockoff, received marketing approval…
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United Laboratories’ UBT251 Receives FDA Green Light for Phase II CKD Study
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that it has received approval from the US Food and Drug Administration (FDA) to assess its Category 1 drug UBT251 in a Phase II study for the treatment of chronic kidney disease (CKD). Drug ProfileUBT251 is a triple agonist targeting…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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Laekna’s LAE120 Receives FDA Approval for Solid Tumor Clinical Trials
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Sino-US biotech company Laekna, Inc. (HKG: 2105) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug LAE120 in advanced solid tumors. The drug, a selective USP1 allosteric inhibitor, has a unique chemical structure that differentiates it from other USP1…
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SynerK’s SNK-2726 Gets FDA Green Light for Phase I Hypertension Study
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SynerK, an RNA-targeted therapy developer with operations in Boston, US, and Beijing and Suzhou, China, announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its SNK-2726. The angiotensinogen (AGT)-targeted small nucleic acid (siRNA) drug is expected to…
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Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory study for its IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein. The trial compares IBI363 monotherapy with Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not…
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Eyebright Medtech Plans Private Placement to Expand Contact Lens Production
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050), an ophthalmic medical device manufacturer, announced plans for a private placement of 3,593,615 shares at RMB 79.2 (USD 10.9) per share. The proceeds, expected to reach RMB 285 million (USD 39 million), will be used to expand its contact lens production…
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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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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…
