Shanghai Junshi Biosciences has filed for a Hong Kong IPO that is expected to raise up to $500 million (see story). Junshi is developing a pipeline of 13 biologic drugs, including immuno-oncology treatments. Its most advanced candidate, toripalimab, is a PD-1 mAb whose NDA is currently being reviewed in China as a second-line treatment for melanoma. Earlier this year, the company also applied for approval to conduct clinical trials of toripalimab in the US. In March, Junshi floated a $30 million convertible bond offering at a $2 billion valuation.  

Nanjing Sanpower, a major China conglomerate, has "sold" its Dendreon pharmaceutical subsidiary by transferring Dendreon to another of Sanpower's holdings, the China retail company Cenbest, in exchange for $868 million of stock (see story). One year ago, Sanpower paid $820 million to acquire Dendreon and its autologous immuno-therapy for prostate cancer. Sanpower explains that Dendreon, as part of Cenbest, will find it easier to raise the money it needs to expand, probably into CAR-T or some other cell therapy. Before the transaction, Sanpower owned 33% of Cenbest. Now it owns 42%.  

Harbour Biomed in-licensed China rights to a bispecific antibody that targets HER2-positive cancers from Glenmark Pharma, an Indian-French biopharma, in a $120 million agreement (see story). Harbour, a Boston-Shanghai company, has an option to manufacture GBR 1302 for the Greater China market. The two companies will collaborate to develop clinical data that supports approvals of GBR 1302 in their respective territories. Glenmark will receive an upfront payment and is eligible for development, regulatory and commercial milestones, plus tiered royalties.  

Tot Biopharm of Suzhou closed a $102 million Series B financing round, which it will use to develop a portfolio of high-end anti-tumor drugs (see story). Tot Bio has over ten drugs in the R&D stage, including three biologics and three small molecules that have been approved for clinical trials. Its Avastin biosimilar has started a Phase III trial. Tot Bio emphasizes foreign partnerships as a means of maximizing the potential of its products. The financing was supported by China Universal GP Limited along with existing investors.

China Medical System (HK: 867) signed a $74.5 million agreement with Can-Fite Biopharma (NYSE: CANF; TASE: CFBI), an Israeli biotech, for greater China rights to two clinical-stage candidates (see story). CMS will have China rights to Can-Fite’s piclidenoson, a treatment aimed at rheumatoid arthritis and psoriasis, along with namodenoson, a treatment for advanced liver cancer and NAFLD/NASH. CMS is making a $2 million upfront payment and will be responsible for $72.5 million of milestones, plus royalties.

Shandong Luoxin Pharma signed a $68 million agreement to acquire greater China rights to Trulance® (plecanatide) from Synergy Pharma (Nasdaq: SGYP) of the US (see story). Trulance treats chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. Luoxin will make a $12 million upfront payment and will be responsible for an additional $56 million of regulatory and sales milestones, plus royalties. In China, Luoxin offers products for needs in the gastrointestinal, respiratory, cardiovascular, infectious and cancer disease sectors.  

Cure Genetics of Suzhou, a startup based on gene editing technologies, closed a $17 million Series A financing, led by Qiming Venture Partners (see story). CTS Capital and Ascendin Investment participated. Founded in 2016, CureGenetics plans to use its expertise in CRISPR gene editing to develop cutting-edge gene-editing technologies. It will apply that expertise towards developing novel medicines and molecular diagnostics.

EdiGene, a Beijing company that uses genome editing technologies to develop novel drugs, completed a $15 Million Series Pre-B financing (see story). Founded in 2015, EdiGene is headquartered in Beijing, with operations in Guangzhou and Boston. The company combines its CRISPR/Cas 9 gene editing technologies with high-throughput genomic screening and functional big data of underlying biology. The financing was led by new investor Lilly Asia Ventures and joined by another new investor Huagai Capital.  

Trials and Approvals

Gilead Sciences (Nasdaq: GILD) received approval from the China National Drug Administration of its combination-drug treatment for HIV-1 (see story). Genvoya® is a single tablet made up of four drugs including tenofovir alafenamide. According to Gilead, Genvoya is the first TAF-based single tablet regimen approved in China for HIV. Since 2003,China has been providing free antiretroviral treatment to all patients with HIV.

BeiGene (Nasdaq: BGNE; HK: 06160), a Beijing oncology biopharma, dosed the first patient in a China Phase III trial of its PD-1 antibody as a first-line treatment for lung cancer (see story). According to BeiGene's count, the trial is the ninth indication for the PD-1 candidate, tislelizumab. The latest trial combines tislelizumab with chemotherapy to treat China patients with squamous non-small cell lung cancer. One year ago, BeiGene out-licensed global rights (ex-Asia) for tislelizumab to Celgene (Nasdaq: CELG) in a $1.4 billion agreement.  

I-Mab Biopharma, a Shanghai company developing immuno-oncology and immuno-inflammation drugs, has been approved to begin Chinatrials of a novel type 2 diabetes treatment (see story). The candidate, TJ103, is an injected, humanized long-acting recombinant glucagon-like peptide-1 (hGLP-1) fused with a hybrid Fc (hyFc). Unlike many diabetes drugs, members of the GLP-1 class have a low risk ofcausing hypoglycemia. China does not currently have any approved long-acting GLP-1 treatments, I-Mab noted.  

Shanghai's I-Mab BioPharma submitted an IND in China for approval to conduct clinical trials of its immuno-oncology multiple myeloma treatment (see story). TJ202/MOR202 is a mAb that is directed against CD38, activating the immune system's killer cells. One year ago, I-Mab in-licensed China rights to the candidate from Germany's MorphoSys (FSE: MOR; NSDQ: MOR) in a $120 million agreement. MorphoSys has started Phase II trials of the drug in Germany and Austria. 

IPO Watch

So far, two young China biopharmas have debuted on the Hong Kong exchange, encouraged by the much-heralded new IPO rules for pre-revenue companies (see story). Unfortunately, the market's response has been lukewarm. Ascletis (HK: 1672) raised $400 million, about the middle of its projected range, but after a week and a half of trading, the company's new shares have declined 15%. BeiGene (Nasdaq: BGNE; HK: 6160) raised $900 million, pricing the offering at the bottom of the range (and a small discount to its NASDAQ quote). It has declined 5% from its offering price in three trading sessions. There are six other pre-revenue China biopharmas that have filed for Hong Kong IPOs and several more planning to do so. The post-IPO performance of the first two could dampen the pricing of these offerings.