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Week in Review: Week in Review: MediLink and BioNTech Form $1.8 Billion ADC Partnership

publication date: Jun 1, 2024
 | 
author/source: Richard Daverman, PhD

Deals and Financings

Suzhou MediLink partnered with Germany’s BioNTech to use MediLink’s TMALIN® antibody-drug conjugate (ADC) platform to discover ADC candidates for several novel targets chosen by BioNTech (see story). MediLink will receive an upfront payment of $25 million and up to $1.8 billion in milestones, plus tiered royalties. MediLink has first negotiation rights to commercialize any candidates in Mainland China. The two companies are very familiar with each other. In October 2023, MediLink announced a deal worth up to $1.1 billion granting BioNTech global rights (ex-China) for MediLink’s next-gen anti-HER3 ADC. 

Asahi Kasei, a Japanese conglomerate known mainly for its chemicals and building materials, made a $1.1 billion offer to buy Calliditas Therapeutics of Sweden (see story). Calliditas is a company focused on rare diseases with one FDA approved drug, Tarpeyo (a delayed-release formulation of the steroid budesonide budesonide) for primary immunoglobulin A nephropathy (IgAN). IgAN is a chronic kidney disease caused by the buildup of antibodies. Asahi Kasei has a medical subsidiary that provides filters for dialysis machines and other conditions. The company wants to have a larger presence in healthcare and plans to expand into the areas of immunology and transplantation. 

Bio-Thera Solutions, a Guangzhou biopharma focused on innovative and biosimilar drugs, sold European rights for a biosimilar to Germany’s STADA Arzneimittel in a $157.5 million agreement (see story). The biosimilar is Golimumab (BAT2506), a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. BAT2506 is a proposed biosimilar to Janssen’s Simponi® (golimumab), which is approved to treat arthritis and other autoimmune disorders. In 2023, Bio-Thera completed a China Phase III trial of BAT2506 in psoriatic arthritis patients, but it hasn’t released the results. 

Suzhou CStone Pharma is selling marketing rights for its lead drug, an anti-PD-L1 monoclonal antibody known as sugemalimab, to Switzerland’s Ewopharma in a deal worth $51 million upfront plus milestones (see story). Ewopharma will own commercial rights for sugemalimab in Switzerland and 18 Central Eastern European countries. CStone will book revenues from supplying the drug to Ewopharma. Ewopharma will be responsible for pricing, reimbursement, sales & marketing and distribution. The EMA and UK MHRA are reviewing the MAA for sugemalimab in combination with chemotherapy as the first-line treatment of metastatic NSCLC. 

Guangzhou Burning Rock Biotech will collaborate with Germany’s Bayer to develop companion diagnostic assays (CDx) based on next-generation sequencing with the goal of improving treatment choices for China patients with cancer (see story). The collaboration will jointly develop NGS-based companion diagnostic products in China for Bayer's growing portfolio of precision cancer therapies. 

Shanghai HuidaGene Therapeutics, a company that develops CRISPR-based genomic medicines, partnered its high-fidelity Cas12 CRISPR nuclease (hfCas12Max) with Synthego of Redwood City, CA (see story). HuidaGene granted Synthego non-exclusive manufacturing and commercialization rights for the hfCas12Max nuclease and optimized gRNA for research. Synthego will also have the right to sublicense the nuclease for therapeutic use. Synthego offers novel CRISPR solutions for developing cell and gene therapies. The companies said the partnership reflects the clinical utility of hfCas12Max and complements Synthego's focus on advanced GMP manufacturing. Terms of the agreement were not disclosed. 

Trials and Approvals

Guangzhou’s Akeso reported that its bispecific antibody, ivonescimab, a combination of PD-1 and VEGF, posted better progression-free survival results than Merck’s Keytruda in patients with non-small cell lung cancer (see story). It is the first time Keytruda was bested by another PD-1 candidate, according to the company. The data came from an interim analysis of ivonescimab in a China Phase III trial in NSCLC patients with positive PD-L1 expression. Specific data will be presented in an upcoming scientific meeting. In late 2022, Summit Therapeutics in-licensed US/EU/Japan rights for ivonescimab in a $5 billion deal. 

San Diego’s Gyre Therapeutics was approved to begin China trials of F230, a selective endothelin receptor antagonist, to treat pulmonary arterial hypertension (see story). Gyre is a clinical-stage biotech that develops anti-fibrotic therapeutics for several chronic organ diseases. The China trial will be run by Gyre Pharmaceuticals, an indirectly controlled Gyre subsidiary located in Beijing. F230 was originally licensed from Eisai via Gyre’s indirect majority stockholder, GNI Group Ltd of Japan. 

Disclosure: none.  


 

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