Deals and Financings

I-Mab will become a completely US-based company with operations in Rockville, Maryland and San Diego, divesting itself of I-Mab Biopharma (Hangzhou), an unconsolidated affiliate (see story). I-Mab Hangzhou will acquire rights to I-Mab’s drug assets in Greater China (eftansomatropin alfa, felzartamab, uliledlimab, givastomig, and lemzoparlimab) for $80 million (dependent on meeting specified goals). The Hangzhou company will acquire I-Mab’s R&D center in Shanghai along with the Hangzhou manufacturing facility. The US I-Mab will own a right of first negotiation to three investigational drug candidates outside of Greater China. 

Anbogen Therapeutics, a Taipei clinical-stage prevision oncology company, raised $12.5 million in a Series A funding round. to advance its two lead drug candidates, ABT-101 and ABT-301 (see story). Both candidates were supported by Taiwan’s National Research Program for Biopharmaceuticals (NRPB) before they were acquired by Anbogen. ABT-101 is a HER2-targeting tyrosine kinase inhibitor, and ABT-301 is a novel small molecule drug that potentiates efficacy of immune checkpoint inhibitors. Anbogen’s A round was led by China Development Industrial Bank with participating from Taian Venture Capital, Maxpro and the National Development Fund. 

Shenzhen’s China Medical System Holdings acquired Greater China rights to Velphoro®, the first iron-based, non-calcium phosphate binder (PB) approved in China for adults and pediatric patients (12-18 years old) with chronic kidney disease (see story). Velphoro® is a chewable tablet containing sucroferric oxyhydroxide. CMS acquired the drug from Winhealth Investment, which previously in-licensed it from Vifor Fresenius Medical Care Renal Pharma. Earlier this month, Velphoro® was approved in China to control serum phosphorus (sP) levels in adults or children. Winhealth signed a 15-year agreement with VFMCRP for the rights in June 2023. 

Japan’s Eisai expects to administer its Alzheimer’s drug Leqembi to 1,500 people in China by the end of March 2025. Leqembi was approved for use in early-stage Alzheimer’s by China’s NMPA in January. Eisai is Biogen’s partner on Leqembi and other Alzheimer’s therapies (see story). Both companies have stopped promoting another approved Alzheimer’s drug from their partnership, Adulhelm®, which caused brain bleed and offered only marginal efficacy. China is the third country in the world to approve Leqembi, following the US and Japan. 

Bayer, a German Life Science company, signed a non-binding Letter of Intent to market a Continuous Glucose Monitoring (CGM) biosensor device owned by Ireland’s Trinity Biotech in China and India (see story). Bayer already has a presence in China’s diabetes market, and the Joint Partnership will allow the company to launch a low cost, high quality, CGM device for monitoring glucose levels in diabetes patients. Both parties intend to negotiate a definitive agreement in the next few months and to form a similar pact for a CGM device in India. Ten days ago, Trinity acquired the CGM assets of Oregon’s Waveform Technologies. 

Trials and Approvals

Jiangsu Hengrui Pharma announced a China launch for Vivjoa® (oteseconazole) in China, a novel oral azole antifungal approved to treat severe vulvovaginal candidiasis (VVC) (see story). In a China Phase III trial, the 2-day oral regimen of Vivjoa showed superior efficacy to the previous standard-of-care, fluconazole, in women presenting with severe VVC. Oteseconazole selectively inhibits fungal CYP51, which is required for fungal cell wall integrity. Because of its chemical structure, oteseconazole has a lower affinity for human CYP enzymes than fungal CYP enzymes. In 2019, Hengrui acquired China rights to Vivjoa from Mycovia Pharma of North Carolina. 

Suzhou Innovent Biologics said its New Drug Application for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, has been accepted for review by China’s NMPA for chronic weight management in obese or overweight adults (see story). Mazdutide is the first GLP-1R/GCGR dual agonist to complete China trials. In its Phase III China study, mazdutide showed better body weight reduction and other weight-related endpoints than the placebo. In 2019, Innovent acquired China rights to the obesity candidate from its long-term partner Lilly, which staged a US launch of the drug in the US two years ago. 

Wuhan iRegene Therapeutics dosed the first patient in a China Phase I/II clinical trial of a novel therapy for Parkinson’s Disease (see story). NouvNeu001 is a chemically induced human dopaminergic neuron precursor derived from iPSC stem cells. Upon transplantation, the cells establish connections with the body's existing neurons with the goal of augmenting cellular secretion functions, The trial will test the efficacy of a stereotactic bilateral intracerebral injection of NouvNeu001 in patients with moderate to advanced Parkinson's disease. iRegene says NouvNeu001 is the world's first iPSC-based, chemically induced universal cell therapy product. 

Sirius Therapeutics began an Australian Phase I, first-in-human clinical trial of its next-gen siRNA candidate aimed at preventing and treating thromboembolic disorders (see story). SRSD107 targets coagulation Factor XI (FXI). Recently, Sirius started a China Phase I trial of SRSD101 to treat dyslipidemia. Sirius, which has a Research Center in San Diego and a Translational Center in Shanghai, believes RNAi medicines offer an expanded range of drug targets with durable efficacy that could address existing unmet needs. In late 2023, Sirius closed a $60 million Series-B financing. 

Guangzhou Fermion Technology was approved to start clinical trials of FZ007-119, a third-gen JAK inhibitor targeting TYK2 JH2 for autoimmune diseases, including moderate to severe plaque psoriasis (see story). The candidate, which is Fermion’s third molecule to begin clinical trials, was developed using Fermion's proprietary Drug Studio AI drug development platform. Fermion says FZ007-119 showed much higher selectivity than older JAK inhibitors, which could offer better safety than existing drugs. An AI and data-driven novel drug development company, Fermion develops potential BIC/FIC candidates for central nervous system and autoimmune indications. 

Disclosure: none.