On the same day of signing the Equity Transfer Agreement, Fosun Kate and Kite revised the original license agreement. According to the revised content, Fosun Kate has obtained exclusive rights to develop, produce, and commercialize Yikaida and Brexu Cel (Fosun Kate’s ongoing project FKC889) within the Kite license area (mainland China, Hong Kong, and Macau) and field (cancer treatment field). Kite will receive a tiered royalty fee of 7% to 13% of drug sales. For Fosun Kate’s pipeline assets, Kite has the right to receive a sales royalty of 2% to 4%. In addition, Fosun Pharma will increase its capital by $10 million in addition to the $27 million equity acquisition, to strengthen Fosun Pharma’s layout in the biopharmaceutical field. It is reported that four CAR-T therapies, including Achilles’ heel injection, have submitted application information in the upcoming 2024 national medical insurance negotiations. Kite, Fuxing Medicine and Gilead 2017 is ...
September 23, 2024 – The clinical trial application (IND) for Pan-KRAS inhibitor JAB-23E73 independently developed by JACOBIO was approved in the United States, and a Phase I/IIa clinical trial for advanced solid tumors will be conducted in the United States. The IND application for China has been submitted, and clinical trials will be conducted in China simultaneously after approval. KRAS is widely present in a variety of tumor mutations. 23%-25% of cancer patients have KRAS mutations. About 2.7 million new tumor patients with KRAS-related mutations each year are expected to benefit from Pan-KRAS inhibitors. JAB-23E73 can inhibit both active and inactive KRAS, and has no significant inhibition on HRAS and NRAS. As an oral KRAS inhibitor, JAB-23E73’s preclinical data showed good pharmacokinetic properties. JACOBIO is committed to providing patients with breakthrough treatment options. The company’s research projects are based on the six major tumor signaling pathways of KRAS, tumor immunity, ...
Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
Insight Database On September 14th, Zhikang Hongyi announced the latest clinical data (NCT05957471) on the safety and efficacy of its globally exclusive antibody conjugated drug BC3195 (CDH3 ADC) in phase I clinical trials for advanced solid tumors at the 2024 ESMO Annual Meeting. The ORR for patients carrying EGFR mutations reaches 80%.Image source: ESMO official website BC3195 uses antibodies with high affinity for CDH3 protein and exhibits good endocytic activity, as well as clinically validated linkers and effective payload vc MMA with bystander effect. The data released this time shows that BC3195 has controllable security and good PK characteristics. BC3195 has shown significant anti-tumor activity in NSCLC patients, with an overall response rate (ORR) of 36.4%, especially for patients carrying EGFR mutations with an ORR of 80%. The data deadline is August 10, 2024. This phase I clinical study enrolled a total of 34 patients, all of whom were late stage ...
Recently, Cardinal Health, the world’s ninth largest medical device company, announced that it has signed a final agreement to acquire Integrated Oncology Network (ION) for $1.115 billion (approximately RMB 7.861 billion) in cash to expand its oncology services business. INO is an independent community cancer center operator with over 50 clinics, more than 100 suppliers, and over 1000 healthcare workers in 10 states across the United States. It provides comprehensive care services for communities in areas such as medical oncology, radiation oncology, urology, and diagnostic testing. After this acquisition, all assets of ION will be integrated into the Navista Cancer Care division of Gardenor, and ION’s clinics will also receive Navista’s artificial intelligence analysis capabilities, as well as PPS Analytics platform support previously acquired by Gardenor through the acquisition of Specialty Networks. Navista is a subsidiary of Gardenor, a cancer diagnosis and treatment department jointly established with oncologists and clinic ...
As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai H drug Hans form ® It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company’s independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for ...
As one of the blue oceans in the field of autoimmune diseases , inflammatory bowel disease (IBD) treatment drugs are sought after and deployed by many multinational pharmaceutical companies. Recently, Eli Lilly acquired Morphic for US$3.2 billion and obtained its core pipeline α4β7 integrin inhibitor MORF-057, further expanding its influence in the field of gastrointestinal diseases. In addition to Eli Lilly, pharmaceutical giants including AbbVie, AstraZeneca, and Merck have laid out IBD treatment drugs and carried out related mergers and acquisitions. Behind the frequent actions, why do multinational pharmaceutical companies favor IBD treatment drugs so much? The dilemma of traditional treatment IBD is a chronic inflammatory bowel disease that mainly affects the digestive system. Its symptoms include severe diarrhea, frequent abdominal pain, blood in the stool, weight loss, and severe cancer. IBD mainly includes two types: ulcerative colitis (UC) and Crohn’s disease (CD). The two IBDs have both overlaps and ...
·ISM001-055 is an innovative drug driven by generative artificial intelligence and fully developed independently by Insilicon Intelligence. It targets TNIK (Traf2/NCK interacting kinase) and has completed phase IIa clinical trials for the treatment of patients with idiopathic pulmonary fibrosis (IPF); ·This study lasted for 12 weeks, and its preliminary results showed that ISM001-055 exhibited good safety in IPF patients and showed a dose-dependent pharmacological trend in improving lung function indicators in patients; ·The positive clinical trial results of ISM001-055 also provide the first conceptual validation for AI driven drug development. Hong Kong, China, September 18, 2024- Yingsi Intelligent, a clinical stage biotechnology company driven by generative artificial intelligence (AI), announced that its pipeline ISM001-055 has achieved positive preliminary research results in a phase IIa clinical trial. ISM001-055 is a “first in class” small molecule inhibitor driven by generative AI for drug discovery and design, targeting TNIK (Traf2/NCK interacting kinase) for ...
Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®, Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
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