BEIJING – Shanghai Junshi Biosciences Ltd. is developing neutralizing antibodies as a potential treatment for COVID-19, and the program will move on to clinical trials soon. Meanwhile, the biotech is set to launch a pre-revenue IPO on Shanghai’s STAR market.

The immuno-oncology firm has been working closely with the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS), and they have obtained multiple strains of neutralizing antibodies that can effectively block viral invasion in laboratory assays and have conducted animal experiments. Junshi is now verifying the preclinical toxicology and in vivo activity of the antibodies.

“We are preparing for an IND for the neutralizing antibodies with domestic and overseas regulatory agencies, including the FDA,” CEO Ning Li told BioWorld.

Ning Li, CEO, Junshi Biosciences

“We believe our collaboration with IMCAS will help accelerate the clinical development of an antibody therapy,” Li said in an earlier statement. “We look forward to facilitating the use of antibody-based therapy as a treatment option for COVID-19, both in China and globally.”

According to Junshi, preliminary in vitro and in vivo studies have verified the blocking activity of the neutralizing antibody strains. The neutralizing antibodies were developed using the company’s antibody development platform to carry out screening for various pathogen host receptors and anti-pathogen antibodies from patients who recovered from COVID-19.

In addition, the company said, IMCAS is equipped with a pathogen immunity development platform and has acquired the coronavirus-related technical secrets. IMCAS has five national key laboratories, the largest fungarium in Asia with nearly 520,000 specimens and the largest common microbial strain collection and management center with nearly 61,000 strains in China.

Last month, Junshi joined the series A+ round of an RNA technology-based biotech startup Stemirna Therapeutics Ltd. by contributing ¥10 million (US$1.4 million) to obtain a 2.86% equity interest. The startup is developing an mRNA vaccine candidate for COVID-19 that has undergone preliminary trials on primates to evaluate its safety and efficacy and is expected to be ready for human clinical trials by mid-April.

“We invested in Stemirna for its mRNA technology platform,” Li told BioWorld. “mRNA is one of the most promising areas, a technology that can be highly complementary to our pipeline.”

Li said neutralizing antibodies and vaccines are two very different approaches to fighting COVID-19, and the company will retain its focus on oncology and immunology. He did not discuss whether Junshi is taking part in vaccine development.

I-Mab Biopharma Ltd. is another Chinese player exploring the use of neutralizing antibodies in the fight against COVID-19. The biotech is initiating the development of its TJM-2, an internally discovered neutralizing antibody against human GM-CSF, to treat cytokine storm caused by COVID-19 in severe and critically ill patients.

Also in the space is U.S. biotech Regeneron Pharmaceuticals Inc., which said that it has isolated hundreds of virus-neutralizing antibodies and plans to initiate large-scale manufacturing of an antibody cocktail therapy by mid-April. The company said it plans to choose the top two antibodies to create a cocktail therapy given as a prophylaxis or a treatment for infected people.

STAR IPO

One day before the announcement about its neutralizing antibodies, Junshi also said the securities regulators in Shanghai would convene a meeting to consider its listing on the STAR board on March 30, meaning the company is one step closer to launching its IPO.

After the green light is given, Junshi will become the first biotech company in China to seek pre-revenue listing in both Hong Kong and Shanghai. The company plans to issue no more than 87.13 million shares and use ¥1.2 billion (US$169 million) on advancing its clinical programs.

“Shanghai's STAR market will be connected with the HKEX. If so, it will certainly play to our advantage when we are listed on both markets,” Li said of the company’s IPO plan on the STAR at the China Biotech Innovation and Investment Conference last year.

The two markets are linked through the Shanghai-Hong Kong Stock Connect scheme, which was launched in 2014. Stock Connect is a cross-boundary investment channel connecting bourses in Shanghai and Hong Kong.

Last year, Junshi recorded losses of ¥766 million. The biotech said it expects to record significant growth in revenues in the first quarter of 2020 as its PD-1 agent, Tuoyi (toripalimab), is approved for marketing in China.

Toripalimab is undergoing studies to evaluate its safety and efficacy in combination with other agents, including I-Mab’s CD73 antibody, TJD-5, Ascentage Pharma’s IAP inhibitor, APG-1387, and Sirnaomics Inc.’ RNAi drug candidate, STP-705.

Meanwhile, its UBP-1211, an adalimumab biosimilar, is under NDA review, and its JS-002, an anti-PCSK9 monoclonal antibody, is undergoing phase II trials in China.

Shares of Junshi (HKG:1877) closed March 24 at HK$27.50 (US$3.55).

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