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Offers and financing
Suzhou MediLink has partnered with German company BioNTech (BNTX) to use MediLink’s TMALIN® antibody-drug conjugate (“ADC”) platform to discover ADC candidates for several novel targets selected by BioNTech (see history). MediLink will receive an upfront payment of $25 million and up to $1.8 billion in milestones, plus tiered royalties. MediLink has priority negotiating rights to market all candidates in mainland China. The two companies know each other very well. In October 2023, MediLink announced a deal worth up to $1.1 billion granting BioNTech global rights (excluding China) for MediLink’s next-generation anti-HER3 ADC.
Asahi Kasei (OTCPK: AHKSY), a Japanese conglomerate known primarily for its chemicals and building materials, made a $1.1 billion offer to buy Calliditas Therapeutics (CALT) from Sweden (see history). Calliditas is a rare disease focused company with a FDA-approved drug Tarpeyo (a delayed-release formulation of the steroid budesonide) for primary immunoglobulin A (“IgAN”) nephropathy. IgAN is a chronic kidney disease caused by the accumulation of antibodies. Asahi Kasei has a medical subsidiary that supplies filters for dialysis machines and other conditions. The company wants to increase its presence in the healthcare sector and plans to expand into the areas of immunology and transplantation.
Bio-Thera Solutions, a Guangzhou biopharmaceutical company specializing in innovative drugs and biosimilars, sold the European rights of a biosimilar to German company STADA Arzneimittel (STDAF) in a $157.5 million deal (see history). 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), approved to treat arthritis and other autoimmune diseases. In 2023, Bio-Thera completed a phase III trial in China of BAT2506 in patients with psoriatic arthritis, but has not published the results.
Suzhou CStone Pharma (OTCPK:CSPHF) is selling the marketing rights to its lead drug, an anti-PD-L1 monoclonal antibody known as sugemalimab, to Switzerland’s Ewopharma in a deal worth an initial $51 million plus milestones. Ewopharma will hold the commercial rights to sugemalimab in Switzerland and 18 countries in Central and Eastern Europe. CStone will record revenues from supplying the drug to Ewopharma. Ewopharma will be responsible for pricing, reimbursement, sales, marketing and distribution. The UK EMA and MHRA are currently reviewing the marketing authorization of sugemalimab in combination with chemotherapy as first-line treatment for metastatic NSCLC.
Guangzhou Burning Rock Biotechnology (BNR) will collaborate with the German Bayer (OTCPK:BAYZF) to develop next-generation sequencing-based companion diagnostic (“CDX”) tests with the aim of improving treatment choices for Chinese cancer patients. 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, has combined its high-fidelity Cas12 CRISPR nuclease (hfCas12Max) with Synthego of Redwood City, California. HuidaGene has granted Synthego non-exclusive manufacturing and commercialization rights for the hfCas12Max nuclease and research-optimized gRNA. Synthego will also have the right to sublicense the nuclease for therapeutic purposes. Synthego offers new CRISPR solutions to develop cell and gene therapies. The companies said the partnership reflects the clinical utility of hfCas12Max and complements Synthego’s focus on GMP advanced manufacturing. Terms of the deal were not disclosed.
Testing and approvals
Akeso of Guangzhou (OTCPK:AKESF) reported that its bispecific antibody, ivonescimab, a combination of PD-1 and VEGF, showed better progression-free survival results than Merck’s (MRK) Keytruda in patients with non-small cell lung cancer. This is the first time Keytruda has been beaten by another PD-1 candidate, according to the company. Data are from an interim analysis of ivonescimab in a phase III trial in China in NSCLC patients with positive PD-L1 expression. Specific data will be presented at an upcoming scientific meeting. End of 2022, Summit Therapeutics (SMMT) rights licensed in the United States, European Union and Japan for ivonescimab in a $5 billion deal.
Gyre Therapeutics of San Diego (GYRE) has been approved to begin trials in China of F230, a selective endothelin receptor antagonist, to treat pulmonary arterial hypertension. Gyre is a clinical-stage biotechnology developing antifibrotic treatments for several chronic organic diseases. The trial in China will be led by Gyre Pharmaceuticals, an indirectly controlled Gyre subsidiary located in Beijing. The F230 was initially licensed by Eisai (OTCPK: ESALF) via Gyre’s indirect majority shareholder, GNI Group Ltd of Japan.
Disclosure: None.
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