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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
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The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
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AbbVie to Acquire ImmunoGen for USD 10.1 Billion, Expanding Oncology Portfolio
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AbbVie (NYSE: ABBV) has reached an agreement to acquire fellow U.S. biotech ImmunoGen (NASDAQ: IMGN) for an equity value of approximately USD 10.1 billion. The transaction is anticipated to close in mid-2025, pending the fulfillment of customary regulatory conditions. This acquisition will enhance AbbVie’s portfolio with Elahere (mirvetuximab soravtansine), an…
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Akeso Biopharma Files New Indication for Penpulimab in First-Line NPC Treatment
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Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1) inhibitor, penpulimab (AK105), seeking approval for its use in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy. The application is currently under review by China’s Center for Drug Evaluation (CDE).…
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Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
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Lepu Biotechnology’s MRG003 Gains Fast-Track Status from U.S. FDA for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug…
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Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
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TG ImmunoPharma Secures U.S. FDA IND Approval for Promising mAb TGI-5 Targeting Multiple Cancers
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TG ImmunoPharma Co., Ltd, based in China, has announced that it has received Investigational New Drug (IND) approval from the U.S. FDA for its proprietary monoclonal antibody (mAb), TGI-5. While the specific target of this molecule remains undisclosed, the company claims it could be a potential global first-in-class treatment. TGI-5…
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AbbVie’s Telisotuzumab-Vedotin Shows Promising Results in NSCLC Phase 2 Trial
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AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
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Boehringer Ingelheim Partners with Phenomic AI to Target Stroma-Rich Cancers
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Boehringer Ingelheim (BI), a German pharmaceutical company, has entered into a partnership with Canada’s Phenomic AI to leverage the latter’s single-cell transcriptomics platform for the discovery of drug targets in stroma-rich cancers, including colorectal and pancreatic tumors. In return for the option to license the identified targets and secure development…
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Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
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Asieris Pharmaceuticals’ Hexvix for Bladder Cancer Accepted for Review by China’s NMPA
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Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Hexvix (APL-1706) for the diagnosis and management of bladder cancer. Hexvix stands as the only globally approved agent…
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Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
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The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
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Beijing Konruns Pharmaceutical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
