Halozyme Therapeutics, Inc. is a biopharmaceutical technology platform company. It engages in developing, manufacturing, and commercializing drug-device combination products using advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The company was founded by Gregory Ian Frost on February 26, 1998 and is headquartered in San Diego, CA.
相关临床试验
33
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1998
已完成
29
87.9%
招募中
1
3.0%
终止
3
9.1%
暂无批准数据
- Final Phase 3 PAPILLON data show first-line RYBREVANT plus carboplatin-pemetrexed achieved median overall survival of 34.3 months versus 27.9 months with chemotherapy alone in EGFR exon 20 insertion NSCLC. - A prespecified crossover-adjusted analysis showed a significant survival benefit, reducing the risk of death by 43 percent (HR 0.57; 95% CI 0.39-0.82; nominal P=0.003). - The combination extended progression-free survival through second disease progression by more than 10 months (28.3 vs 17.5 months; HR 0.59; nominal P<0.0001). - Results were presented at the IASLC 2026 World Conference on Lung Cancer and represent the longest reported median overall survival in this historically poor-prognosis population.
- Final Phase 3 PAPILLON analysis showed first-line amivantamab plus chemotherapy achieved a median overall survival of 34.3 months in EGFR exon 20 insertion-positive advanced NSCLC. - Chemotherapy alone produced a median OS of 27.9 months, with the protocol-specified hazard ratio of 0.87 not reaching statistical significance. - A prespecified crossover-adjusted analysis, accounting for 76% of control patients who crossed over to amivantamab, showed a 43% reduction in risk of death. - Progression-free survival through second disease progression favored the combination by more than 10 months, with no new safety signals at longer follow-up.
- Alteogen signed an exclusive option and license agreement with Novartis for its hyaluronidase ALT-B4, with maximum payments reaching $3.223 billion if all options and milestones are achieved. - Novartis secured multiple options to develop and commercialize subcutaneous formulations of biopharmaceuticals using ALT-B4, choosing it over Halozyme's Enhanze platform. - ALT-B4's patent protection extends into the early 2040s, while Halozyme's core composition-of-matter patents expire between 2027 and 2029, reinforcing Alteogen's long-term exclusivity position.
- Alteogen signed an option and licensing agreement with Novartis worth up to 4.4 trillion won ($3.2 billion) to develop and commercialize subcutaneous formulations using its ALT-B4 technology. - Novartis gains exclusive rights, through multiple options, to develop and commercialize SC formulations for multiple products, with Alteogen also receiving royalties on net sales after commercialization. - ALT-B4 is a recombinant human hyaluronidase that converts intravenous biologic drugs into subcutaneous formulations, shortening administration time and improving patient convenience. - The deal marks Alteogen's fourth ALT-B4 licensing agreement with a global pharmaceutical company this year, with major SC conversion projects expected to commercialize sequentially from 2029.
- CMS published a proposed rule that would subject subcutaneous formulations of Keytruda and Opdivo to Medicare price negotiations at the same time as their IV counterparts. - The rule aims to close a loophole that allows drugmakers to extend patent-protected life through formulation switching, a practice known as "evergreening." - Opdivo and Keytruda had combined global sales of $41 billion last year, with IV patents expiring in 2028 and biosimilars expected by December 2028. - CMS could exempt the newer formulations if biosimilars of the IV versions enter the market and compete on price, creating uncertainty around the 2029 negotiation round.
- Alteogen reported first-half 2026 sales of 140.5 billion won, a 37% year-on-year increase, with net profit more than doubling to 101.3 billion won. - Keytruda Qlex, the first commercialized SC product using ALT-B4, posted Q2 sales of $463 million, a 262% jump from $128 million in the prior quarter. - The company secured ALT-B4 platform license agreements with Tesaro (GSK) and Biogen in Q1 and is in final-stage negotiations for additional deals. - Alteogen plans to shift from upfront/milestone revenue toward a product sales-based growth model as commercial momentum accelerates.
- CDR-Life has appointed Dimitrios Chondros, MD, as Chief Medical Officer to oversee clinical development of the company's M-gager® T cell engager platform for cancer and autoimmune diseases. - Dr. Chondros brings over 20 years of global drug development experience, including previous roles as Chief Medical Officer at Halozyme and Global Development Team Leader for Avastin® at Genentech. - The appointment comes as CDR-Life advances its first oncology program in clinical trials and expands its pipeline of highly selective T cell engagers targeting solid cancers and autoimmune diseases.
- Monash University researchers demonstrate that subcutaneous administration of cancer immunotherapies with hyaluronidase is more effective than traditional intravenous delivery for the first time. - The enzyme hyaluronidase breaks down hyaluronan in subcutaneous tissue, enabling high-volume injections while improving treatment access to the lymphatic system where immune responses are generated. - This delivery method offers dual benefits of enhanced therapeutic efficacy and improved patient convenience by reducing treatment complexity and pain compared to intravenous infusion. - The findings provide new rationale for transitioning monoclonal antibody immunotherapies from intravenous to subcutaneous administration, particularly for treatments targeting tumor-draining lymph nodes.
- Alteogen CEO Jeon Tae-yeon announced the company is in advanced negotiations with approximately 10 pharmaceutical companies for its ALT-B4 subcutaneous injection platform, with another major deal potentially worth billions imminent. - The Korean biotech has already secured licensing agreements worth over $1.7 billion combined with companies including AstraZeneca ($1.35 billion) and MSD ($432 million) for its proprietary hyaluronidase enzyme technology. - ALT-B4 enables large-volume subcutaneous delivery of drugs traditionally administered intravenously, reducing administration time from seven to eight hours to just minutes. - The company plans to commercialize six or more products over the next five to six years as its technology platform gains traction in the global pharmaceutical market.
- Skye Bioscience announced its 2026 clinical development plan for nimacimab, a first-in-class peripherally-restricted CB1 receptor inhibitor for obesity treatment. - The company's Phase 2a CBeyond trial demonstrated clinically meaningful additional weight loss when nimacimab was combined with semaglutide compared to semaglutide alone, with no plateau observed at 26 weeks. - Key 2026 milestones include Q1 extension data updates, Q3 topline 52-week results, and launch of an adaptive Phase 2b trial evaluating multiple doses as monotherapy and in combination with incretin therapies. - Nimacimab showed a favorable safety profile with placebo-like tolerability and no increase in neuropsychiatric adverse events compared to previous CB1-targeting drugs.
