Deals and Financings

Geneseeq, a Nanjing-Toronto company that offers genetic sequencing tests for cancer, completed a $114 million Series D financing led by China Reform Holdings Corporation (see story). Geneseeq uses next-gen sequencing to provide decision-making tools for physicians. The company describes its pan-genomic test as a precision medicine support system for targeted drugs, immunotherapies and cancer risk assessment. The Geneseeq Prime test detects genetic abnormalities in 425 cancer-related genes. Lilly Asia Ventures and SoftBank China Venture Capital also participated in this round. In the three previous fundings, Geneseeq raised a total of $86 million.

Shanghai's Elpiscience Biopharma closed a $100 million Series B round to develop its portfolio of 12 novel immunotherapy candidates through pre-clinical and clinical testing (see story). The round was led by Hyfinity Investments. Just two years old, Elpiscience bases its drug development on its understanding of tumor biology and immunology. The company says its candidates must have a differentiated biology and then show efficacy in a platform that tests the molecule's benefits in clinical settings. Two weeks ago, Elpiscience signed a $21.4 million collaboration with two China banks to build a GMP manufacturing facility in Suzhou.

Shanghai Zerun Biotech completed a refinancing by raising $29 million in venture capital to pay down debt (see story). The company exchanged 11% of its shares for the $29 million in a round that included six VCs, led by Hillhouse Capital. Zerun, a subsidiary of Walvax Biotech (SHE: 300142), is developing novel first and second generation HPV vaccines and a Hand, Foot, Mouth Disease vaccine. Its affordable first-gen HPV vaccine is in Phase III tests, and it has six candidates in preclinical development. After the financing, Walvax holds a 65% stake in Zerun.

Innovative Cellular Therapeutics (ICT), a Shanghai-US CAR-T company, raised $28.6 million in a Series B+ round, led by LH Ventures, a Chongqing VC (see story). Proceeds from the funding will be used to advance ICTCAR014, ICT’s next-gen CD19-targeting armored CAR-T cell therapy into a 2020 US clinical trial. ICTCAR014 expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. It is already being tested in China trials. The company did not disclose the amount of the funding, though it was announced in a private equity website.

Roche (SIX: RO) paid $750 million upfront and invested another $400 million in Sarepta Therapeutics (NSDQ: SRPT) of Cambridge, MA to acquire ex-US rights to Sarepta's clinical-stage treatment for Duchenne muscular dystrophy (DMD), a rare disease (see story). Sarepta said there are 60,000 cases of DMD in China alone, though Roche will have to devise a strategy for China insurance reimbursement to succeed in China. As an treatment for a rare condition, the gene therapy will be very expensive. Under the agreement, Sarepta is eligible to receive up to an additional $1.7 billion consisting of regulatory/sales milestones and royalties.

Trials and Approvals

Zai Lab (NSDQ: ZLAB) of Shanghai announced China approval for Zezula (niraparib), its PARP inhibitor, as a maintenance therapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer (see story). Zai believes Zezula is a potential best-in-class PARP inhibitor for ovarian cancer patients because of its compelling clinical data, once-daily dosing and pharmacokinetic properties, including an ability to cross the blood-brain barrier. Zezula is Zai's first drug approved in mainland China. In 2016, the company in-licensed greater China rights to Zezula from Tesaro, which was acquired by GlaxoSmithKline (NYSE: GSK) earlier this year.

Sinovac Biotech (NSDQ: SVA), a Beijing vaccine company, announced China approval for its varicella zoster vaccine to prevent chicken pox in children from 1 to 12 years old (see story). The company, which noted that the approval is the first China vaccine approved under new, more stringent regulations, said it intends to seek similar approvals in other countries that include a varicella vaccine in their immunization programs. Although chicken pox is relatively benign, complications may arise in the form of pneumonia and encephalitis, and it can develop into shingles in older adults.

Luye Pharma (HK: 2186) submitted an NDA to the US FDA for a new chemical drug that treats major depressive disorder (see story). LY03005 is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), and one of the active metabolites is a serotonin-norepinephrine reuptake inhibitor (SNRI). The NDA is based on Phase II data for LY03005, following discussions with the FDA. Luye expects LY03005 will have a more rapid onset with higher efficacy than current medications, while it helps to preserve patients' sexual function.

Disclosure: none.