预约演示
Trailing AstraZeneca and Merck, Junshi reports phase 3 ovarian cancer success for Lynparza rival
2023-04-12
临床3期临床结果上市批准引进/卖出
Junshi Biosciences plans to engage with regulators “in the near future.”
Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space.
Junshi Biosciencesrck won the first approval for a PARP inhibitor in China in 2019, but their monopoly onChinese PARP inhibitorChinese PARPwas short-lived. The next year, Zai Lab won approval for GSK’s Zejula and Jiangsu HengJunshiarmaceuticals got the green light to seAstraZeneca BeiGMerck & Co.theLynparzan May 202ovarian cancerave slightly different labels and, according to a 2022 paper, Lynparza and Zejula are the most widely used.
AstraZeneca thicMerckf competitors, Junshi sees an PARPrtunity for another PARP inhibitor. The Chinese drug developer secured access to a candidate, Zai Labib, in 2020 by forGSKg a joint ventJiangsu Hengrui PharmaceuticalsBeiGeneLynparzaZejula
At the time of the deal, Impact was Junshimonths into a phase 3 clinical trPARPdesigned to show senaparib extends progression-free survival when givesenaparibintenance therapy to BRCA-positive ovarianImpact Therapeuticster first-line chemotherapy. The top-line findings, released late Tuesday in the U.S., showed the primary endpoint met the predefined efficacy boundary.
The top-line data release lacks the figures behind the hit on the primary endpoint and details osenaparib drug candidate performed on other measures of safety and efficacy. JunshiBRCA-positive ovarian cancerile for approval, though, and plans to work with Impact to engage with regulators “in the near future.”
In the absence of data from the trial, it is hard to gauge how senaparib is likely to fare in a market with established incumbent products, but the little that is known poinJunshisome potential ways for Junshi and Impact to try to differentiate the treatment.
Jianjun Zou, president of global research and development at Jusenaparibled the trial as “the first phase 3 clinical study of a domestically developed PARP inhibitor that has achieved positive results foJunshinced ovarian cancer maintenance treatment following first-line therapy” in a statement. Zou added that the PARP inhibitor significantly extended progression-free survival regardless of BRCA mutation status. BRCA mutation, according to local pathological diagnosis, was on the inclusion criteria for the clinical trial.
AiRuiYi was the first domestically developed PARP inhibitor tJunshithe Chinese market, but its approval in 2020 was limited to patients with the germliPARPRCA mutation who had undergone second-line or abovadvanced ovarian cancerwas the first PARP drug approved in China in first-line and recurrent maintenance treatmPARPsettings regardless of biomarker status, but it originated outside of the country.
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