Week in Review:

Deals and Financings

Jiangsu QYuns Therapeutics filed for a Hong Kong IPO to underwrite development of its portfolio of clinical stage biologic antibody drugs for autoimmune and allergic diseases (see story). The company has developed a pipeline of nine candidates using its rabbit-based discovery platform that it expects will be more affordable than the competition. QYuns says the platform offers a 50-fold increase in B cells for more screening, better affinity and greater diversity than mouse-based technology. However, QYuns’ first approved drug will probably be QX001S, a ustekinumab biosimilar aimed at psoriasis, rather than one of its novel candidates. QYuns has submitted a BLA for QX001S in China, the first for the indication. 

Taiwan’s PharmaEssentia (TPEx: 6446), a global biopharma that develops hematology and oncology candidates, acquired a myeloid immune checkpoint antibody for solid tumors from WuXi Biologics Ireland (see story). Myeloid checkpoints are receptors on the myeloid cell surface that mediate inhibitory signals, inhibiting cellular phagocytosis or suppressing T cells. PharmaEssentia will have exclusive global rights to research, develop, manufacture and commercialize the checkpoint antibody candidate. It will assume responsibility for all preclinical and clinical development efforts. PharmaEssentia will make an upfront payment plus pay milestones and sales royalties to WuXi Biologics. i

Trials and Approvals

Biogen (NSDQ: BIIB) , a Cambridge, MA biopharma, announced US approval for Tofidence (tocilizumab-bavi), a biosimilar to Roche’s Actemra® (tocilizumab), which Biogen in-licensed from Guangzhou's Bio-Thera (SHA: 688177) (see story). The candidate, which is the first tocilizumab biosimilar approved in the US, is indicated for various arthritis indications, especially for young people. In 2021, Bio-Thera sold ex-China rights for tocilizumab-bavi to Biogen for a $30 million payment due once the candidate posted results from a US Phase III trial showing non-inferiority to Roche’s target drug. Biogen has exclusive regulatory, manufacturing and commercial rights to Tofidence outside of China. 

Everest Medicine (HK: 1952) reported positive data for Asian patients in a Phase III study of NefIgArd, a treatment for IgA Nephropathy (see story). Nefecon® was shown to lower circulating levels of IgA-IC IgA-containing immune complexes, which accumulate in renal tissue, triggering inflammation and scarring of the glomeruli. Nefecon® is a delayed release formulation of corticosteroid that is designed to remain intact until it reaches the lower small intestine. Everest expects a positive ruling on its China NDA for Nefecon later this year. In 2019, the company acquired greater China rights to the drug from Sweden’s Calliditas in a $121 million agreement. 

Arctic Vision, a Shanghai ophthalmology biopharma, has completed enrollment in a China Phase III trial of Arcatus® to treat uveitic macular edema, a cause of blindness (see story). The candidate is designed to deliver therapies through the suprachoroidal space in the back of the eye, which is expected to allow the active ingredients to work longer with less harm to the rest of the eye. In 2020, Arctic Vision in-licensed rights to the drug, known as Xipere®, from Clearside Biomedical, a US company, for $35.5 million. The drug is administered using Clearside’s SCS Microinjector™ device. 

Suzhou Transcenta (HK: 06628) was approved to start a US Phase III trial of Osemitamab, a CLDN18.2 antibody, in patients with metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma (see story). The candidate will be administered as a first-line therapy in patients with HER2-negative, CLDN18.2 disease along with chemotherapy and/or Opdivo (nivolumab), a PD-1 drug. Transcenta says Osemitamab is a second-gen CLDN18.2 targeting antibody with improved binding affinity and enhanced cellular cytotoxicity. The US trial is part of a global Osemitamab trial being conducted by Transcenta, which has already been approved to begin the China arm. 

Guangzhou Magpie Pharma reported its lead candidate, TBN, improved some key markers of ALS disease progression in a China Phase II trial, though it did not meet the trial’s endpoints (see story). TBN statistically improved Grip Strength (32.4%, P=0.037), a quality of life measurement that no other ALS therapy has provided, though Magpie’s candidate did not improve the broader endpoints: changes in the ALSFRS-R score and forced vital capacity. Magpie has also conducted successful Phase II trials of TBN – a multi-functional tetramethylpyrazine nitrone candidate – in patients with acute ischemic stroke and diabetic kidney disease. 

Disclosure: none.