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Week in Review: Mabwell Sells Ex-China Rights to Rare Disease Therapy in $412 Million Deal

publication date: Mar 2, 2024
author/source: Richard Daverman, PhD

Deals and Financings

Mabwell, a Shanghai-San Diego biotech, sold ex-China rights for 9MW3011 to Disc Medicine of Watertown, MA in a deal worth up to $412 million. Mabwell will receive $10 million upfront (see story). 9MW3011 is designed to lower the serum level of iron, regulating iron homeostasis in vivo. It is expected to treat patients with rare diseases including β-thalassemia, polycythemia vera and other conditions related to iron homeostasis. 9MW3011, which has been approved to start trials in China and the US, was developed in Mabwell’s San Diego Innovation R&D Center. 

Zhuhai’s Biotheus formed a multi-year collaboration with Bitterroot Bio of Palo Alto to discover novel approaches that modulate the immune system and regulate inflammation, with the goal of addressing atherosclerosis and other potentially fatal cardiovascular conditions (see story). Biotheus will design novel monoclonal and multi-specific antibodies using its proprietary platforms. Bitterroot will add its expertise in cardiovascular medicine and biology to the partnership. Bitterroot is a cardio-immunology company that focuses on the impact of the immune system on cardiovascular health. 

Jiangsu Nhwa Pharma formed a China partnership to distribute a Teva Pharma therapy that treats two neurodegenerative and movement disorders - chorea associated with Huntington’s disease and tardive dyskinesia in adults (see story). Teva’s Austedo is the only vesicular monoamine transporter 2 inhibitor approved by the US FDA for adults with either condition. Austedo, a deuterated drug, replaces hydrogen atoms with deuterium, which is expected to lower metabolism rates and facilitate less frequent dosing. Nhwa’s focus is on providing new therapies for China’s neuro-psychiatric health sector. 

AstraZeneca has returned most of the global rights for Roxadustat to FibroGen, though it will retain the rights for China and South Korean, where the drug is approved (see story). Roxadustat is an oral HIF-PH inhibitor that promotes red blood cell production. It is approved in China to treat patients with anemia from renal failure, whether they are on dialysis or not. The companies were not able to satisfy US regulators that Roxadustat was effective. In 2023, Roxadustat generated $281 million in China revenues, which should climb over $300 million this year after it is approved to treat anemia from MDS. 

Company News

AstraZeneca announced that it will locate its fifth global strategic center in Shanghai, joining centers in Cambridge, UK, Boston and Gaithersburg in the US, and Gothenburg, Sweden (see story). The Shanghai center will differ from the other centers because it will include China/Asia commercial and production operations along with R&D. The new center will play a part in AZ’s global strategy, according to the company. Earlier this year, AZ made a dramatic statement of its interest in China's biopharma innovation by spending $1.2 billion to acquire Gracell Bio, a CAR-T development company headquartered in Suzhou. 

Trials and Approvals

Shanghai’s CARsgen Therapeutics (HK: 2171) was approved for a China launch of zevorcabtagene autoleucel, its autologous BCMA CAR-T product, in patients with relapsed or refractory multiple myeloma (see story). Patients must have progressed after at least 3 lines of therapy (including a proteasome inhibitor and immunomodulator agent). The approval of zevorcabtagene autoleucel is based on an open-label, single arm, multi-center China Phase II clinical trial. CARsgen is conducting a separate Phase Ib/II trial in North America in the same patient population. The BCMA CAR-T candidate is CARsgen’s first approved product. 

Longbio Pharma (Suzhou) released results from a Phase II trial of its lead drug, LP-003, showing 100mg of LP-003 offered the same efficacy as 300mg of omalizumab, the current standard of care, in patients with allergic rhinitis (see story). Both therapies are anti-IgE antibodies, but LP-003, which binds a new target, has shown better bioactivity than omalizumab in subgroup analysis. LP-003 is a novel monoclonal anti-IgE antibody that was generated and engineered by Dr. Nai-chau Sun, who co-founded Longbio and also invented omalizumab. Longbio believes LP-003 has potential to be best-in-class. 

Shanghai Everest Medicines (HK: 1952) and Kezar Life Sciences (NSDQ: KZR) of South San Francisco will start a China Phase IIb trial of their partnered drug, zetomipzomib, in patients with lupus nephritis (see story). Zetomipzomib is a novel first-in-class, selective immunoproteasome inhibitor with therapeutic potential for several autoimmune diseases. In 2023, Everest announced a $132 million deal ($7 million upfront) for China distribution rights to the candidate. At the time, Kezar said Everest, with its focus on renal and autoimmune diseases for Asian patients, was a good partner for zetomipzomib

BioCity Biopharma, a clinical-stage company located in Wuxi, has enrolled all 120 participants in the IgA nephropathy (IgAN) cohort of a Phase II clinical study its oral endothelin A (ETA)-receptor selective antagonist (see story). SC0062 is being tested in two forms of chronic kidney disease: IgAN and diabetic kidney disease (DKD). The company expects to complete enrollment of the DKD cohort by the end of Q2 2024. SC0062 is an ETA receptor small molecule antagonist designed with high selectivity to ensure efficacy and avoid safety risks. BioCity develops differentiated therapeutics for cancer and autoimmune disorders including chronic kidney diseases. 

Suzhou Innovent Biologics (HKEX: 01801) dosed the first patient in an Australian Phase I trial of IBI3002, a global first-in-class bispecific antibody for asthma (see story). IBI3002 is a humanized bispecific antibody that targets cell surface IL-4Rα and the alarmin cytokine TSLP, discovered by Innovent to treat inflammatory diseases, including asthma. TSLP is an epithelial cell-derived alarmin cytokine that triggers both T2 and non-T2 inflammation in asthma. Innovent believes IBI3002, with its dual targets, has the potential to treat several inflammatory diseases. Innovent develops novel medicines for oncology, metabolic, autoimmune and ophthalmology indications. 

Disclosure: none. 


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