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Government and Regulatory

According to a Wall Street Journal report, China and the US are close to solving the accounting rules crisis that threatens to de-list 261 China companies from US exchanges (see story). The list of affected biopharma companies includes BeiGene, Legend Bio, Zai Labs, and many more.

Under the proposed agreement, US-listed China companies could transfer their audit working papers and records to Hong Kong, where US auditors approved by the Public Company Accounting Oversight Board (PCAOB) would have full access to them. Previously, China maintained that granting complete access to company records would damage its national security. 

Deals and Financings

Shanghai Hansoh Pharma (3692.HK) will partner with Beijing’s Global Health Drug Development Center to develop and commercialize the Center’s novel COVID-19 therapy (see story). GDI-4405 is a pre-clinical oral candidate that targets the coronavirus 3CL protease. In pre-clinical tests, GDI-4405 has shown potent inhibition of SARS-CoV-2 replication with good bioavailability and safety.

Hansoh will make a $2 million upfront payment, and it will be responsible for up to $268 million in milestones, plus royalties on sales. Formed in 2016, GHDDC is a non-profit organization formed by the Gates Foundation, Tsinghua University, and the Beijing Municipal Government. 

Shanghai Bao Pharmaceuticals closed a Series B round with over $100 million to support development of its recombinant protein and antibody drug candidates, including commercialization (see story). Bao Pharma will also advance its pre-clinical projects into clinical trials.

The company is building a 75,000 square meter facility in Laodian Industrial Park, located in Shanghai’s Baoshin District, which will house its R&D operations and manufacturing facilities for recombinant protein drugs and injected drugs. The round was led by Oriental Fortune Capital and included Haitong Innovation and Sun Rock Capital. 

Porton Advanced Solutions, a Suzhou CDMO offering gene and cell therapy services, completed an $80 million Series B round to expand its business into new markets (see story). The company has built an integrated CDMO platform that provides plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy, and microbial vectors used for gene therapy (MVGTs).

Currently, Porton has a 40,000 square feet R&D and GMP production facility that has been operating for over two years. It expects a 160,000 square feet commercial production facility will be operational around the end of 2022. The financing was led by China Merchants Group funds. 

Lee's Pharmaceuticals (0950.HK) of Hong Kong entered a $78.9 million deal with Windtree Therapeutics for global rights to a therapy for respiratory distress syndrome in pre-term infants (see story). The therapy includes Surfaxin®, a lyophilized lucinactant, and the AeroSurf non-invasive drug/device.

Lee’s, which had previously acquired China rights to the therapy, will be fully responsible for all costs of global development. There is no additional upfront payment, but Lee’s will pay up to $78.9 million in milestones, plus royalties on sales. RDS often occurs in preterm infants if the lung is not fully developed with natural surfactant. 

I-Mab (IMAB), a Shanghai immunoncology biotech, announced the company and its senior management will purchase up to $40 million of its outstanding American Depository Shares (see story).

The company’s stock price has been hit harder than most China biopharmas in the year-long price slide. In July 2021, I-Mab’s ADSs hit a high price of nearly $82, but they are now changing hands for $6, a 92% decline, leaving I-Mab with a valuation of $500 million, which is less than its cash on hand. 

Trials and Approvals

Shanghai Alpha Biopharma reported the last patient visit has taken place in its Phase II/III trial of zorifertinib in patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) and CNS metastases (see story). The trial enrolled 492 patients at 55 study sites.

In previous clinical and preclinical tests, zorifertinib showed high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and a safety profile similar to other EGFR-TKI drugs. AlphaBio acquired zorifertinib from AstraZeneca (AZN). 

Shanghai Clover Biopharma (2197.HK) reported its COVID-19 vaccine candidate met its primary endpoint in a global Phase II/III trial in adolescents (12 to 17 years) (see story). Following treatment with SCB-2019 (CpG 1018/Alum), adolescent trial participants experienced 2-fold higher neutralizing antibody titers compared to young adults (18 to 25 years).

Previously, SCB-2019 proved to be highly protective against COVID-19 among young adults. Clover will seek approval in China, the EU and WHO for use of the vaccine across age groups as a COVID-19 vaccine and a universal COVID-19 booster vaccine. 

Ranok Therapeutics, a Boston-Hangzhou company started US clinical trials of a novel therapy for solid tumor cancers or diffuse large B-cell lymphoma (see story). Ranok develops drug candidates based on its novel approach to protein degradation.

The Phase I/II trial will test safety and tolerability of RNK05047, the first therapy based on Ranok's proprietary CHAMP™ technology and the first BRD4 protein degrader to start clinical trials. One year ago, Ranok raised $40 million in a B round from China investors. 

Sirnaomics (2257.HK), a Suzhou-Maryland RNA company, has dosed the first patient in a US Phase I/II trial of its leading siRNA (small interfering RNA) candidate in patients with facial squamous cell skin cancer in situ (see story). STP705 is already being tested in six other Phase II trials for various cancers.

The 30/60/90μg dose escalation study will evaluate the safety, tolerability and efficacy of STP705 administered by intralesional injection. STP705 is a siRNA product designed to knock down both TGF-β1 and COX2 gene expression and is administered via a polypeptide nanoparticle (PNP)-enhanced delivery. 

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