Black Jack 3D
Transactions and Financing
SHANGHAI – San Diego biotech Mabwell has sold offshore rights to 9MW3011 in China to Disc Medicine (IRON) of Watertown, Mass., in a deal valued at up to $412 million. Mabwell will pay $10 million upfront (see story). 9MW3011 Designed to reduce serum iron levels and regulate iron homeostasis in the body. It is expected to be used to treat patients with rare diseases, including beta-thalassemia, polycythemia vera, and other conditions related to iron homeostasis. 9MW3011 was developed by Mabowell San Diego Innovation R&D Center and has been approved to start trials in China and the United States.
Zhuhai-based Biotheus has a multi-year partnership with Palo Alto-based Bitterroot Bio to explore new ways to modulate the immune system and modulate inflammation with the goal of addressing atherosclerosis and other potentially fatal cardiovascular diseases. Biotheus will use its proprietary platform to design novel monoclonal and multispecific antibodies.bitter root will add its expertise in cardiovascular medicine and biology to the partnership. Bitterroot is a cardiac immunology company focused on the impact of the immune system on cardiovascular health.
Jiangsu Enhua Pharmaceuticals has entered into a partnership in China to distribute Teva Pharma’s (TEVA) therapies, which treat two neurodegenerative diseases and movement disorders – chorea associated with Huntington’s disease and adult tardive dyskinesia ( See story). Teva’s Austedo is the only vesicular monoamine transporter 2 inhibitor approved by the U.S. FDA for use in adults with both diseases. Austedo is a deuterated drug, replacing hydrogen atoms with deuterium and is expected to decrease metabolic rate and reduce dosing frequency. Nhwa’s focus is on bringing new treatments to the neuropsychiatric health field in China.
AstraZeneca (AZN) has returned most global rights to Roxadustat to FibroGen but will retain rights to the drug’s approval in China and South Korea (see story). Roxadustat is an oral HIF-PH inhibitor that promotes erythropoiesis. It is approved in China to treat patients with anemia caused by kidney failure, whether or not they are on dialysis. The companies were unable to convince U.S. regulators that Roxadustat was effective. Roxadustat’s revenue in China was $281 million in 2023 and will exceed $300 million this year after being approved to treat anemia in MDS.
company news
AstraZeneca announced that its fifth global strategic center will be located in Shanghai, following Cambridge in the United Kingdom, Boston and Gaithersburg in the United States, and Gothenburg, Sweden. The Shanghai center is different from other centers in that it will include China/Asia commercial and production operations as well as R&D. The company said the new center will play a role in AZ’s global strategy. Earlier this year, AZ splashed out $1.2 billion to acquire Suzhou-based CAR-T developer Gracell, a dramatic expression of interest in Chinese biopharmaceutical innovation.
Tried and Approved
Shanghai-based CARsgen Therapeutics (OTCPK: CRTHF, HK: 2171) has approved the launch of autologous BCMA CAR-T product zevorcabtagene autoleucel in China for the treatment of patients with relapsed or refractory multiple myeloma. Patients must have progressed after at least 3 lines of therapy, including proteasome inhibitors and immunomodulators. The approval of zevorcabtagene autoleucel was based on an open-label, single-arm, multicenter Chinese 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 product candidate is the first product approved by CARsgen.
Lonbio Pharmaceuticals (Suzhou) released the results of a phase II trial of its lead drug LP-003, showing that 100 mg of LP-003 is as effective as 300 mg of omalizumab (the current standard of care) in patients with allergic rhinitis. Both therapies are anti-IgE antibodies, but LP-003, which binds the new target, showed better bioactivity than omalizumab in subgroup analyses. LP-003 is a new monoclonal anti-IgE antibody developed and designed by Dr. Sun Naizhou, co-founder of Longbo Biotech, who also invented omalizumab. Longbo Biotech believes that LP-003 has the potential to become best-in-class.
Shanghai-based Everest Medicines (HK: 1952) and South San Francisco-based Kezar Life Sciences (KZR) will initiate a Chinese Phase IIb trial of their partner drug zetomipzomib in patients with lupus nephritis. Zetomipzomib is a novel first-in-class selective immunoproteasome inhibitor with the potential to treat a variety of autoimmune diseases. In 2023, Everest announced a $132 million deal ($7 million upfront) to acquire China distribution rights to the candidate. At the time, Kezar said Everest, which focuses on treating renal and autoimmune diseases in Asian patients, would be a good partner for zetomizomib.
BioCity Biopharma, a clinical-stage company based in Wuxi, has enrolled all 120 participants in the IgA nephropathy (IgAN) cohort of its Phase II clinical study of an oral endothelin A (ETA) receptor-selective antagonist. SC0062 is being tested in two forms of chronic kidney disease: IgAN and diabetic nephropathy (DKD). The company expects to complete enrollment of the DKD cohort by the end of the second quarter of 2024. SC0062 is an ETA receptor small molecule antagonist with high selectivity to ensure efficacy and avoid safety risks. BioCity develops differentiated therapies for cancer and autoimmune diseases, including chronic kidney disease.
Suzhou Innovent Biological Products Co., Ltd. (OTCPK: IVBIY, Hong Kong Stock Exchange: 01801) dosed the first patient in the Australian Phase I trial of IBI3002, the world’s first asthma bispecific antibody. IBI3002 is a humanized bispecific antibody discovered by Innovent that targets cell surface IL-4Rα and the alarmin cytokine TSLP and is used to treat inflammatory diseases including asthma. TSLP is an epithelial cell-derived alarmin cytokine that triggers T2 and non-T2 inflammation in asthma. Innovent Biologics believes that IBI3002 has dual targets and has the potential to treat a variety of inflammatory diseases. Innovent develops new drugs for oncology, metabolism, autoimmune and ophthalmic indications.
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