Deals and Financings

InnoCare Pharma of Beijing priced its Hong Kong IPO at the top end of its proposed range to raise $288 million at a $1 billion valuation, according to insiders (see story). The company develops immunotherapies for cancer and autoimmune diseases. It has three molecules in clinical trials, including its lead product, a BTK inhibitor under NDA review in China for leukemia and lymphoma. The company discovers candidates through its own research and in-licenses products from other biopharmas. Hong Kong has not completed an IPO since January because of the coronavirus outbreak, though the health crisis may have helped a biopharma company like InnoCare.

SciClone Pharma signed an $84 million deal to acquire Greater China rights to a novel drug conjugate aimed at solid tumors from Tarveda Therapeutics of Massachusetts (see story). PEN-866, the initial clinical program in Tarveda’s HSP90 binding miniature drug conjugate platform, is designed to bind to the activated form of Heat Shock Protein 90 (HSP90) to accumulate and release its topoisomerase 1 inhibitor payload in solid tumors. SciClone will make a $4 million upfront payment, be responsible for up to $75 million in milestones, and can make a $5 million investment in Tarveda.

Yizhun Intelligent, a Beijing AI-based medical scan diagnosis company, completed a Series B funding round of $14 million, led by Wondfo Bio-industry Fund and joined by existing investors Hina Group and Qingsong Fund (see story). Founded in 2017, Yizhun uses machine learning to develop products. So far, the company has launched intelligent detection systems for lung nodules, mammography targets and several lung diseases. It also partnered with IBM Watson to create an AI medical imaging research platform called the "Darwin Intelligent Scientific Research Platform." Its products are used in over 400 China hospitals.

Trials and Approvals

Jiangsu Hansoh Pharma has been approved to market Ameile (almonertinib) in China to treat non-small cell lung cancer (NSCLC) (see story). The once-daily tablets are aimed at NSCLC patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive disease who have progressed after another EGFR tyrosine kinase inhibitor therapy. Hansoh says Ameile is the second 3rd generation EGFR TKI approved for the indication. Hansoh completed a $1 billion IPO in Hong Kong during 2019.

Shanghai's Zai Lab (NSDQ: ZLAB) reported China accepted its sNDA for review of Zejula®, its PARP1/2 inhibitor, as a first-line maintenance therapy (see story). The filing is for use in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. In 2019. Zejula was approved in China as a maintenance therapy among a similar group of patients following second or third chemotherapy rounds.

InxMed (Shanghai) Co. has dosed the first patient in a Phase Ib trial of its focal adhesion kinase (FAK) inhibitor in melanoma patients (see story). The trial will conducted in Australia and the US in patients with metastatic uveal melanoma or NRAS mutant metastatic melanoma. IN10018 will be tested as a monotherapy and in combination with Roche's MEK inhibitor Cotellic™ (cobimetinib), which was approved to treat melanoma in 2015. Previously, InxMed was approved to start a China Phase I trial of IN10018 in patients with advanced or metastatic gastric cancer.

Coronavirus Outbreak

BioNTech SE (NSDQ: BNTX) of Germany will partner with Shanghai Fosun Pharma (SHA: 600196; HK: 02196) in a $135 million deal to develop BioNTech's mRNA vaccine candidate for COVID-19 in China (see story). Fosun will make a $50 million investment in BioNTech and pay up to $85 million in milestones. The two companies will work jointly to develop BNT162 in China and will share gross profits from China sales. Fosun will be in charge of China commercialization, while BioNTech will retain full rights in the rest of the world.

Zhejiang Hisun Pharma (SHA: 600267) reported that its in-licensed anti-viral drug, favipiravir, was effective in China trials to treat COVID-19 patients (see story). Hisun, which acquired China rights to favipiravir from Japan's Fujifilm in 2016, said the drug reduced the mean time-to-virus-clearance for patients with the coronavirus to four days from eleven days in the control group, which was treated with a lopinavir/ritonavir combination. In the trial, which was conducted at the Third People's Hospital of Shenzhen, favipiravir caused only a few adverse reactions.

CanSino Biologics (HK: 6185) of Tianjin and China's Academy of Military Medical Sciences received regulatory approval to start China clinical trials of a novel coronavirus vaccine (see story). The vaccine was described as an adeno-associated virus serotype 5 (AAV5) vector encoding the SARS-CoV-2 spike protein. The Phase I trial will test the COVID-19 vaccine in Wuhan among healthy volunteers. In 2014, CanSino and the AMMS formed a collaboration to bring an AMMS-discovered Ebola vaccine to market. That candidate was approved in 2017.

Roche (SIX: ROG) has started a global Phase III test of Actemra/RoActemra (tocilizumab), the company's arthritis treatment, in hospitalized adults with severe COVID-19 pneumonia (see story). Actemra blocks the IL-6 receptor to slow a person's immune response. The randomized, double-blind, placebo-controlled trial will enroll 330 patients in the US and elsewhere. Roche will assess the safety and efficacy of Actemra in combination with standard of care compared to placebo. China has already included Actemra as part of its COVID-19 treatment guidelines.

Moderna (NSDQ: MRNA) started a Phase I trial of its COVID-19 vaccine (mRNA-1273) in healthy volunteers, the first coronavirus vaccine to begin clinical testing (see story). Moderna is a Cambridge, MA biotech that develops novel mRNA products for therapeutics and vaccines. Its mRNA-1273 encodes for a prefusion stabilized form of the Spike (S) protein, but unlike most vaccines, does not contain any form of the virus itself. Moderna has previously developed mRNA vaccines for SARS, Zika and the cytomegalovirus (CMV).

Sanofi (EPA: SAN) and Regeneron Pharma (NSDQ: REGN) of New York State have started clinical trials of Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 (see story). Kevzara, a fully-human mAb that inhibits the IL-6 receptor, has been approved since 2017 in the US and EU as a treatment for rheumatoid arthritis. In COVID-19 patients, the drug is aimed at inhibiting the overwhelming inflammatory response in the lungs of patients with serious disease. Sanofi also plans to start trials of Kevzara outside the US in the near future.

Sorrento Therapeutics (NSDQ: SRNE), a San Diego-Suzhou biopharma, has produced a preclinical batch of STI-4398 (COVIDTRAP) protein to test its ability to prevent SARS-CoV-2 virus from infecting ACE2-expressing cells (see story). STI-4398 is an ACE2 (angiotensin-converting enzyme 2)-Fc fusion protein (COVIDTRAP). It binds the spike protein of the SARS-CoV-2 virus. Without the ability to penetrate target cells, the SARS-CoV-2 virus cannot replicate and spread itself. The treatment has the potential to generate passive immunity and could shield at-risk populations.

Disclosure: none.