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Week in Review: AkesoBio, a Zhongshan mAb Biopharma, Files for $300 Million Hong Kong IPO

publication date: Feb 8, 2020
 | 
author/source: Richard Daverman, PhD

Deals and Financings

AkesoBio, a Zhongshan novel drug discovery and development biopharma, filed for a $300 million Hong Kong IPO to develop its portfolio of novel mono- and bi-specific antibodies (see story). The company has built a portfolio of 18 mAbs that are in either CMC or clinical stages of development for oncology, inflammation, autoimmune and cardiovascular diseases. In general, Akeso develops bispecific antibodies using a PD-1 antibody as a backbone. Late last year, Akeso Biopharma closed a $150 million Series D round of financing led by Loyal Valley Capital and Sino Biopharm (HK: 1177).

Shenzhen Lachesis Mhealth raised $21 million in a Series B+ round to support its patient care medical device offerings for hospitals (see story). In 2018, Lachesis completed a $29 million Series B financing. The company's Intelligent Hospital Ward System includes a diagnosis and treatment assistant, wireless monitoring and other services to improve patient care. Lachesis says its product targets the post-acute-care market in general hospitals. Shenzhen Capital Group and ShenZhen GTJA Investment Group both participated in the B+ round; GTJA led the earlier B round.

Shanghai Junshi Bio (HK: 1877) invested $1.4 million in Stemirna Therapeutics, a Shanghai company developing mRNA vaccine therapeutics for cancer (see story). Junshi, which made the investment as part of an A+ round, acquired an 3% stake in Stemirna. The two companies will jointly develop novel drugs and combination therapies Formed in 2016, Stemirna identifies tumor-specific antigens, loading them onto a single mRNA strand. Junshi, which has 13 molecules in development, was the first China company approved to market a PD-1 candidate in China, Tuoyi.

Wuhan Coronavirus Outbreak

China researchers have filed for a China Invention Patent to remdesivir, a Gilead (NSDQ: GILD) candidate to treat 2019-nCoV (see story). According to people familiar with China patent law, they are unlikely to succeed because Gilead owns global IP for the molecule and for its use as a coronavirus treatment. The experts further noted the researchers did not file for a Compulsory Use patent, a more "heavy handed" approach that would give China authorities the right to use the drug for a dire need. The experts reasoned the choice shows China does not want to unsettle global IP standards. Instead, as the China researchers noted, if Gilead agrees to supply remdesivir, China would not choose to enforce the patent.

The Bill & Melinda Gates Foundation will commit up to $100 million in response to the 2019 novel coronavirus outbreak (see story). The funding is divided into three initiatives: $60 million to accelerate the discovery, development and testing of vaccines, treatments and diagnostics for 2019-nCoV; $20 million to detect, isolate and treat people who have the virus with the goal of containing the disease; and $20 million to help public health authorities in sub-Saharan Africa and South Asia populations who live in extreme poverty and tend to suffer disproportionately from global epidemics.

Gilead Sciences (NSDQ: GILD), working together with China authorities, has started a China trial of its antiviral remdesivir as a treatment for 2019-nCoV coronavirus (see story). The trial will enroll 270 patients and be based in the China-Japan Friendship Hospital in Beijing. It is a Phase III randomized, double-blind, placebo-controlled multicenter study that will evaluate the efficacy and safety of remdesivir in hospitalized adult patients with mild and moderate 2019-nCoV infections. Researchers expect to complete the trial on April 27. Gilead said remdesivir has previously shown efficacy in models of the MERS and SARS coronaviruses.

BGI, China's largest genomic sequencing company, opened the Huo-Yan (Fire Eye) laboratory in Wuhan, an emergency coronavirus testing laboratory designed to examine 10,000 samples daily (see story). The lab was built by BGI and its partners in five days. To diagnose samples, BGI will use PMseq, its qPCR rapid detection 2019-nCoV reverse transcription kit, a coronavirus metagenomic sequencing test, along with the company's DNBSEQ-T7 sequencer and analysis software. The test was approved by China's NMPA under emergency rules.

Trials and Approvals

Shanghai's Zai Lab (NSDQ: ZLAB) has started two China clinical trials: a Phase I combination test of Zezula (niraparib), a PARP inhibitor, paired with a bi-specific PD-1 for gastric cancer, plus a bridging trial of margetuximab for HER2-positive breast cancer (see story). Two months ago, Zai was granted its first China drug approval for Zezula (niraparib) as an ovarian cancer treatment. It will be administered together with a bispecific PD-1 x LAG-3 DART® molecule in-licensed from MacroGenics (NSDQ: MGNX). The second trial will administer a HER2 mAb, margetuximab, to HER2-positive breast cancer patients.

Bio-Thera Solutions (BSE: 500087) of Guangzhou reported positive top-line results from a Phase III clinical trial of its Avastin biosimilar (see story). The trial compared the overall response rate (ORR) of BAT1706 to Avastin as a first-line treatment for non-squamous non-small cell lung cancer. The company plans to file for approval of the Avastin biosimilar this year in China, the US and the EU. One year ago, Bio-Thera out-licensed developing country rights for BAT1706 to India's Cipla Pharma. Bio-Thera is already marketing a Humira® biosimilar for auto-immune conditions in China.

Disclosure: none. 

 


 

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