BioSpace Global Roundup, Jan. 2
While things have been somewhat quiet due to the long holiday period, some pharmaceutical companies have continued to announce updates to their businesses and pipelines. Here’s a roundup of the few announcements.
Sinovac – Beijing-based Sinovac Biotech Ltd. announced the China National Medical Products Administration (NMPA) approved and issued a Product license for the company’s varicella vaccine to prevent the varicella-zoster virus in children from ages 1 to 12 years old. Varicella, commonly known as “chickenpox,” is a highly contagious infectious disease caused by the varicella-zoster virus. Varicella usually affects children and is relatively benign, but complications may arise in the form of pneumonia and encephalitis. Sinovac’s Varicella Vaccine is derived from Oka strain and performed in the company’s proprietary Human Diploid Cell. A phase III efficacy study conducted among 6,000 subjects in 2017 shows the protection rate of the vaccine is 87.1%.
Check-Cap – Israel-based Check-Cap Ltd. announced positive results from its pilot study of the C-Scan System in the United States. Check-Cap’s C-Scan system is billed as “the first and only preparation-free ingestible scanning capsule-based system for the prevention of colorectal cancer through the detection of precancerous polyps.” The prospective, multi-center, open-label, single-arm study was designed to evaluate the safety, usability and subject compliance of the C-Scan System. The study included 28 evaluable patients, more than two-thirds of whom were considered to be of average risk for colorectal cancer. Each patient ingested a C-Scan capsule and also underwent a fecal immunochemical test (FIT) as well as a comparative colonoscopy, which was performed by an independent gastroenterologist who was blinded to the corresponding test results. The primary endpoint of the study was to evaluate the incidence of device or procedure-related serious adverse events. Secondary endpoints included patient compliance, subject satisfaction and device and procedure-related performance. Due to the sample size, the study was not designed to be powered for statistical significance. Following the trial, analysis of the results showed an agreement between C-Scan and colonoscopy in the detection of polyps was consistent with data from the post-CE approval study. Alex Ovadia, chief executive officer of Check-Cap, said completing the first U.S. study in the U.S. is an important milestone for the company. It will now work toward the initiation of a pivotal study in late 2020 in the United States.
Zai Lab – China-based Zai Lab Limited announce the NMPA approved its New Drug Application for Zejula (niraparib) as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. In June, Zai Lab licensed the rights to Zejula, a once-daily PARP inhibitor from Tesaro Therapeutics, prior to that company’s acquisition by GlaxoSmithKline. The approval marks the first for Zai Lab in mainland China. Additionally, the NMPA approval marks the first PARP inhibitor with Category 1 designation and manufactured in Mainland China. Zai Lab helped launch the drug in Hong Kong. Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths in China each year. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients diagnosed with distant metastatic disease. Zai Lab anticipates filing a supplemental NDA for Zejula with the NMPA as a first-line monotherapy maintenance treatment of platinum-responsive ovarian cancer patients soon after GlaxoSmithKline files with the relevant global health authorities.