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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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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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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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Magnet Biomedicine and Eli Lilly Partner on Molecular Glue Therapeutics
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US-based molecular glue specialist Magnet Biomedicine has entered into a collaboration and license agreement with Eli Lilly & Co. (NYSE: LLY). The alliance aims to discover, develop, and commercialize molecular glue therapeutics in oncology. Collaboration DetailsSpecifically, Magnet’s TrueGlue discovery platform will be utilized to identify molecular glues capable of inducing…
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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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Grand Pharma Sells Telix Shares for AUD 143M to Fund Clinical Programs
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) announced the sale of 4,947,181 shares in its Australia partner Telix Pharmaceuticals Ltd (ASX: TLX) for AUD 143 million (USD 89 million). The proceeds will be used for clinical development targeting unmet clinical needs, including programs in collaboration with Telix. Grand Pharma…
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SciClone Pharmaceuticals Licenses Eisai’s Tasurgratinib for China
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China-based SciClone Pharmaceuticals Inc. announced a licensing agreement with Eisai Co., Ltd (TYO: 4523), securing exclusive development and commercialization rights to the Japanese firm’s tasurgratinib succinate (E7090) in China. Drug ProfileTasurgratinib, an orally available selective inhibitor of FGFR 1-3, was approved in Japan in September of last year. It is…
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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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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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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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Burning Rock and MGI Tech Partner to Advance Oncology Precision Medicine
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China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has entered into a strategic partnership with fellow domestic company MGI Tech Co., Ltd (SHA: 688114), a gene sequencing specialist. The collaboration aims to promote the clinical application and global business development of oncology precision medicine, with a focus on regulatory filing…
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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…
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Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. The application seeks approval for Keytruda’s use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC)…
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Summit Therapeutics and Pfizer Collaborate on Ivonescimab-ADC Combo for Solid Tumors
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Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for ivonescimab, announced a clinical collaboration with Pfizer (NYSE: PFE) to evaluate the combination of ivonescimab, Akeso’s PD-1/VEGF bispecific antibody (BsAb), with Pfizer’s antibody drug conjugates (ADCs) in multiple solid tumors. Collaboration DetailsUnder the agreement, Summit…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (aged 12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA set…
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MGI Tech Partners with Oncoclínicas&Co to Advance Precision Medicine in Brazil
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China-based gene sequencing specialist MGI Tech Co., Ltd (SHA: 688114) has partnered with OC Medicina de Precisão of Oncoclínicas&Co, Latin America’s largest cancer treatment group. The collaboration aims to promote precision medicine innovation in Brazil, offering efficient and personalized cancer diagnosis and treatment. Partnership DetailsThe partnership combines OC Medicina de…
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AWS Collaborates with MSK to Accelerate Oncology Research via AI and Cloud Tech
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Amazon Web Services (AWS) announced a strategic collaboration with Memorial Sloan Kettering Cancer Center (MSK), a world-leading cancer research institute based in New York. The partnership aims to leverage artificial intelligence (AI), high-performance computing (HPC), and cloud technologies to drive breakthroughs in oncology research and personalized treatment development. Collaboration DetailsAWS…
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Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as…
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Epitopea and Merck Partner to Identify Cryptigen Tumor Antigens
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UK-based RNA immunotherapy developer Epitopea announced a licensing and research cooperation agreement with US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK). The partnership aims to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. These antigens, derived from non-coding regions of the genome, are shared, non-mutated, and…
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Hepalink Pharmaceutical’s H1710 Heparanase Inhibitor Approved for Phase I Study
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of its proprietary drug candidate H1710, a heparanase (HPA) inhibitor, for the treatment of advanced solid tumors. Drug ProfileH1710 is designed…
