Week In Review: Mabwell Out-Licenses Rare Disease Drug For $412.5 Million

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Deals and Financings

Shanghai Mabwell Biosciences out-licensed global rights (ex-China) for a rare disease drug to Disc Medicine (IRON) of Cambridge, MA in a $412.5 million agreement (see story).

The candidate, 9MW3011, is a first-in-class macromolecule drug that regulates iron homeostasis in vivo and aims to treat rare diseases, including β-thalassemia and polycythemia vera. It has been approved to start trials in the US and China. Mabwell will receive $10 million upfront, $402.5 million in milestones, plus single digit royalties on sales. 

Aprinoia Therapeutics, a company developing products for neurodegenerative diseases, agreed to merge with a SPAC at an implied business combination value of $280 million (see story). The SPAC is Ross Acquisition Corp II (ROSS). The company’s lead product is a PET tracer for tau, which targets tauopathies and is currently in a China Phase III trial.

In addition, Aprinoia announced it has out-licensed China rights for the tau tracer to an unnamed large biotech company for an unspecified amount. Aprinoia believes its tracer has a higher specificity than older generations of the diagnostic tool. Now headquartered in Cambridge, MA, Aprinoia was previously based in Hong Kong and Taipei. 

GenScript ProBio of Nanjing, a biologics CDMO with operations around the globe, raised $224 million in a C round (see story). ProBio offers end-to-end CDMO services from drug discovery to commercialization for antibodies, cell, and gene therapies. The company said it would use the capital to increase manufacturing capacity, advance its R&D offerings, and acquire companies that add services.

After the funding, GenScript Biotech (GNNSF), a gene synthesis company, will continue to own 70% of ProBio, down from 80%, even though it added about $30 million to the funding. Legend Capital led the C round. 

Shanghai CARsgen formed a $181 million collaboration with Huadong Medicine to commercialize CARsgen’s lead asset, a BCMA CAR T-cell, in mainland China (see story). CT053 (zevorcabtagene autoleucel (zevor-cel)), is an autologous CAR T-cell product for relapsed/refractory multiple myeloma (R/R MM).

CARsgen will receive $30 million upfront and up to $151 million in milestones. In October 2022, CARsgen submitted an NDA for CT053 to China’s NMPA. In late 2022, CARsgen reported positive data from a pivotal China Phase I/II trial for CT053. 

Structure Therapeutics, a South San Francisco-Shanghai company developing GPRC drugs based on structural design, filed for a $100 million IPO on the Nasdaq (see story). Previously known as ShouTi, Structure is developing novel oral therapeutics for chronic diseases in pulmonary, metabolic, and cardiovascular indications that are unmet needs.

The company was co-founded by CEO Raymond Stevens, a Scripps Research expert in structure-based drug discovery, along with Schrodinger (SDGR), an AI molecular-based drug discovery company. Structure is headquartered in South San Francisco with an R&D facility in Shanghai. 

Nanjing IASO Bio, a clinical-stage CAR-T company, completed a $75 million Series C1 funding to develop its portfolio of over 10 novel autologous and allogeneic CAR-T and biologic products that target oncology and autoimmune indications (see story).

China’s NMPA has accepted an NDA for the company’s lead product, Equecabtagene Autoleucel, a fully human BCMA CAR-T injection for relapsed/refractory multiple myeloma (r/r MM). The funding will support R&D of the company's pipeline and the commercial launch of Equecabtagene Autoleucel. 

Shanghai Ronovo Surgical closed a new financing to conduct a multi-discipline clinical trial for its first robotic laparoscopic surgery device, Carina™ (see story). With the latest funding, Ronovo has raised more than $50 million since 2020.

The company’s Carina device is an innovative modular system that enables configurable robotic assistance across multiple specialties. Led by LongRiver Investments, Ronovo’s latest round was supported by existing investors Lilly Asia Ventures, Vivo Capital, Matrix Partners China, and GGV Capital – with CEC Capital acting as exclusive financial advisor. 

Tigermed, a full-service Hangzhou CRO, acquired Marti Farm, a European CRO based in Zagreb, Croatia (see story). Marti Farm offers pharmacovigilance, clinical operations, and regulatory services to pharma and cosmetic companies. Over the past 12 years, it has worked with 150 companies in 50 countries.

Tigermed said it expects the acquisition will increase its presence in Europe, as it offers CRO services to biopharmas, while it expands Marti Farm’s cloud-based pharmacovigilance capabilities to global clients. The terms of the acquisition were not disclosed. 

Trials and Approvals

Shanghai Henlius Biotech has been approved to launch its anti-PD-1 mAb in China as a first-line treatment for extensive stage small cell lung cancer (see story). Hansizhuang (serplulimab injection), the first novel mAb developed by Henlius, is also the first anti-PD-1 approved as a first-line therapy for SCLC globally.

The anti-PD-1 will be administered in combination with carboplatin and etoposide. Previously, Hansizhuang was approved in China as a first-line therapy in two non-small cell cancer indications: Microsatellite Instability-High (MSI-H) solid tumors and squamous non-small cell lung cancer. 

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