Deals and Financings

Baidu (NSDQ: BIDU), one of China's major internet/AI companies, is talking with investors about raising $2 billion to fund a new China drug development and diagnostics company (see story). It believes the $2 billion fundraising will take two years to complete. The new company plans to use Baidu's AI division for initial discovery of new products. According to Reuters, which broke the story, Baidu would not be the controlling shareholder of the company. Baidu did not comment on the news, which cited two unnamed sources who claimed direct knowledge of the plan.  

Huadong Medicine (SHZ: 0963) formed a partnership with Exscientia, an AI drug discovery company in the UK, to discover novel small-molecule candidates for oncology (see story). The initial project is focused on transcription control of DNA damage response genes. The approach will treat patients with defective DNA damage repair mechanisms, a condition that leads to high mutation frequency, in patients with ovarian and breast cancer. The partnership will advance Huadong's strategic goal of developing innovative medicines.  

CANbridge Pharma of Beijing has formed a second gene therapy collaboration with the Horae Gene Therapy Center at the University of Massachusetts Medical School (see story). The latest sponsored research program will develop novel customized adeno-associated virus (AAV) vectors aimed at neuromuscular diseases. The program will be directed by Miguel Sena-Esteves, PhD, Associate Professor of Neurology at the UMass Medical School, Earlier this year, CANbridge formed a collaboration with Guangping Gao, PhD, Director of the Horae Center to study gene therapy-based treatments for rare diseases. 

Hualan Genetic Engineering agreed to develop three Harbour BioMed novel monoclonal and bispecific antibodies in return for China marketing rights to the candidates (see story). Hualan Genetic, previously a company focused on biosimilars, will be responsible for preclinical and process development. It will also make an $8.75 million upfront payment, plus pay royalties. Harbour BioMed, which is headquartered in the US with R&D facilities in China, will retain the rights to the antibodies in the rest of the world. Both companies will collaborate on clinical developments and drug manufacturing.  

Gannex Pharma, a subsidiary of Hangzhou's Ascletis Pharma (HK: 1672), partnered with Israel's Galmed Pharma (NSDQ: GLMD) to test a combination of ASC41 and Galmed's Aramchol (SCD 1 inhibitor) to treat non-alcoholic steatohepatitis (NASH) (see story). Gannex's ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist that was recently approved to begin China clinical trials for NASH. The company expects to provide topline results from a Phase I trial by the end of 2020. Financial details of the transaction were not disclosed.  

Trials and Approvals

Zai Lab (NSDQ: ZLAB) of Shanghai announced China's NMPA approved the use of Zejula® (niraparib), a PARP inhibitor, as a first-line maintenance treatment for ovarian cancer (see story). In December 2019, Zejula was approved for use in second or third-line maintenance therapy in China. Zai recently started a China bridging trial for the drug as a late-line treatment for ovarian cancer. In 2016, Zai acquired Greater China rights to the drug from Tesoro Pharma, now a part of GSK.  

Beijing's CANbridge Pharma was approved to launch Hunterase® (idursulfase beta injection) in China for Hunter syndrome, a rare disease (see story). It is the first approval in CANbridge's rare disease portfolio and the first enzyme replacement therapy approved in China for Hunter syndrome. CANbridge in-licensed China rights to Hunterase in early 2019 from Korea's GC Pharma (KRX: 006280). Hunter syndrome is one of the 121 diseases on China's Rare Disease List. 

Junshi Bio (HK: 1877; SHA: 688180) of Shanghai reported the US FDA granted Breakthrough Designation to its PD-1 for nasopharyngeal carcinoma, the first China biopharma awarded BTD for a PD-1 drug (see story). In May of this year, the FDA granted toripalimab orphan drug designation for the same indication. Though relatively rare in the US, NPC is one of the most common malignant tumors in China. In late 2018, toripalimab became the first China-developed PD-1 approved for use in China, where it is marketed as Tuoyi for melanoma patients.

Everest Medicines, a Shanghai in-licensing company, has begun dosing patients in a China Phase III trial of a treatment for autoimmune renal disease (see story). Everest acquired China rights to Nefecon from Calliditas Therapeutics of Stockholm. Calliditas has completed a Phase III trial of the candidate in patients with IgA nephropathy (IgAN), a rare renal disease for which there are no treatments. Everest will enroll some China patients in the 160-person global Part B Phase III trial, which is being conducted to validate the biomarker, proteinuria.

Zion Pharma, headquartered in Hong Kong, has started a US Phase I trial of its novel HER2 inhibitor that is designed to address brain metastases of HER2+ breast cancer (see story). Founded in 2018, Zion says it uses its DMPK expertise to develop candidates with best-in-class potential to inhibit cancer, especially those that cross the blood-brain barrier. The trial is being conducted at US sites that include the Dana Farber Cancer Institute and the Duke Cancer Institute. Zion has research operations in Shanghai and Suzhou.

Disclosure: none.