Coronavirus Pandemic

Junshi Biosciences (HK: 1877) out-licensed ex-China rights for a therapeutic antibody aimed at preventing and treating COVID-19 to Eli Lilly (NYSE: LLY) (see story). JS016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and blocks the binding of viruses to host cell surface receptor ACE2. The antibody research was developed jointly by Junshi and the Institute of Microbiology, Chinese Academy of Science. Lilly plans to file an IND and start trials in the US in Q2 of 2020.

Sorrento Therapeutics (NSDQ: SRNE), a San Diego-Suzhou biopharma, formed a partnership with Mount Sinai Health System of New York City to develop a triple antibody product designed to provide a protective shield against SARS-COV-2 infection (see story). The three antibodies recognize three specific regions of the SARS-CoV-2 Spike protein. The antibody is expected to provide up to two months of protection for people returning to work or as a therapy for infected patients. The antibodies were identified by examining the blood of 15,000 people who recovered from COVID-19.

Harbour BioMed, a Rotterdam, US and China biotech, used its antibody discovery technology to help Dutch researchers identify a mAb that prevents SARS-CoV-2 virus from infecting cultured cells (see story). In 2002, the researchers, who are associated with Utrecht University and the Erasmus Medical Center in the Netherlands, had previously worked on discovering mAbs for the 2002/2003 SARS-CoV outbreak. They tested promising candidates from that project in samples of the latest coronavirus. HBM used its H2L2 transgenic mouse technology to generate the antibody, which has the potential to either treat or prevent the infection.

Shanghai Fosun Pharma (SHA: 600196; HK: 02196) and BioNTech (NSDQ: BNTX) of Germany will start China trials of their partnered mRNA COVID-19 vaccine candidate as soon as China approves the trials (see story). The news came as BioNTech and Pfizer (NYSE: PFE) began US and EU trials of the vaccine. Fosun made a $50 million investment in BioNTech and agreed to pay up to $85 million in milestones to form a China development partnership for BNT162. Fosun and BioNTech will share profits from China sales, though Fosun will be in charge of commercialization.

Ansun Pharma, a San Diego anti-infectives company with ties to China, has added a COVID-19 US arm to its global Phase III trial of DAS181, which was testing the drug in patients with lower respiratory tract parainfluenza virus infection (see story). DAS181 is a recombinant sialidase protein that cleaves sialic acid on the surface of epithelial cells in the respiratory track to block virus entry. DAS181 has shown activity against several flu viruses. Ansun said DAS181 was administered to a small number of COVID-19 patients in Wuhan with positive, though anecdotal, results.

Deals and Financings

TargetRx, a Shenzhen company developing small molecules therapeutics for cancer, completed a $21.2 million Series A financing, led by CCB Principal Capital Management (see story). Founded in 2014, the company is developing novel third/fourth generation candidates with the goal of avoiding acquired drug resistance. Proceeds from the funding will be used for clinical studies of the company’s chronic myeloid leukemia and non-small cell lung cancer treatments and other R&D. The founder of TargetRx, Dr. Yihan Wang, has previously discovered several first-in-class novel drugs.

Immunophage, a Nanjing biotech, closed a $14 million Pre-A financing, led by Jinfang Hongrui Investment Management, to support its immune-regulating candidates for cancer, autoimmune and neurodegenerative indications (see story). The company's lead cancer projects have dual or multiple anti-tumor properties that pair inhibitors of tumor growth with mechanisms that reverse the tumor's immunosuppressive environment. IPG1094 inhibits tumor growth and the formation of target-mediated myeloid suppressor cells. IPG7236 inhibits tumor metastasis and tumor-related regulatory T cell infiltration. Immunophage's R&D operations are in Shanghai's Caohejing Pujiang High-Tech Park.

Trials and Approvals

CANbridge Pharma of Beijing announced China's NMPA approved the launch of Nerlynx® (neratinib) as an extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer (see story). Patients must have previously received adjuvant trastuzumab therapy. Although trastuzumab has been shown to reduce recurrence in HER2-positive breast cancer following surgery, up to 25% of trastuzumab patients experience a return of their disease. In 2018, CANbridge in-licensed greater China rights to Nerlynx from Puma Pharma of the US in a $70 million agreement.

Suzhou Innovent Bio (HK: 01801) announced its approved anti-PD-1 drug, Tyvyt® (sintilimab injection), met its progression-free primary endpoint in a China Phase III trial in patients with non-small cell lung cancer (see story). Tyvyt® was administered in combination with Gemzar® and platinum chemotherapy in first-line advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). In January, Innovent released positive results from a similar NSCLC trial testing Tyvyt with ALIMTA® and platinum chemotherapy. The company's China NDA based on the earlier trial has been accepted for review.

HighTide Therapeutics, a Shenzhen-Maryland biopharma, reported its lead drug, HTD1801, met its primary endpoint in a China Phase IIa trial in patients who have both non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM) (see story). Although HighTide did not release specific results, the company said its candidate reduced absolute liver fat along with several secondary endpoints including glycemic control and markers associated with liver injury. The trial enrolled 100 patients who received HTD1801 500mg, 1,000mg or placebo BID for 18 weeks. The molecule was generally well-tolerated without any unexpected side effects.

Shanghai's Zai Lab (NSDQ: ZLAB) received word that China's Center for Drug Evaluation will review its NDA for omadacycline, a novel tetracycline designed to overcome resistance, under priority rules (see story). In February 2020, China's NMPA accepted the omadacycline NDA to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Zai in-licensed greater China rights to the antibiotic in 2017 from Boston-based Paratek (NSDQ: PRTK), which was approved for a US launch of omadacycline in 2019. CABP is a common secondary infection associated with respiratory viruses like COVID-19.

Ascentage Pharma (HK: 6855) of Suzhou was granted Orphan Drug designation in the US for HQP1351, a third-gen BCR-ABL inhibitor aimed at treating drug-resistant chronic myeloid leukemia (CML) (see story). The candidate is specifically designed to target BCR-ABL mutants including T315I that cause drug resistance. In July 2019, HQP1351 was cleared by the FDA to start a Phase Ib study in the US. It is currently being tested in a China pivotal Phase II trial, and Ascentage plans to submit a China NDA for HQP1351 this year.

Disclosure: none.