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Deals and Financings
Hansoh Pharma sold ex-China rights for its B7-H4 ADC to GSK in a $1.57 billion deal in which $85 million is provided upfront, plus royalties on any sales (see story). The candidate, HS-20089, targets B7-H4, a transmembrane glycoprotein in the B7 superfamily that is highly expressed in various cancers but limited in normal tissues.Hansoh has started a China Phase I clinical study of HS-20089 for gynecologic cancers, especially ovarian and endometrial cancers with possibilities in other solid tumors. Hansoh is an active deal-marker, but most of its agreements have been in-licensings from other companies. OrbiMed has raised $4.3 billion in commitments for three healthcare funds, including $751 million for its OrbiMed Asia V fund (see story). OrbiMed Private Investments IX was funded with $1.865 billion, and OrbiMed Royalty & Credit Opportunities IV has $1.71 billion.In March 2022, the investment company announced closings for the same funds with remarkably similar investment capital in each, showing that institutional investors continue to trust OrbiMed’s drug development expertise despite the difficult markets for venture capital exits from life science companies. LianBio (LIAN) will sell its greater China rights for mavacamten, a cardiovascular drug, to Bristol-Myers Squibb (BMY) for $350 million (see story). In 2020, LianBio acquired the China rights for mavacamten from MyoKardia. Bristol-Myers Squibb bought MyoKardia later that year for $13.1 billion.LianBio’s deal for the drug was $187.5 million, but $127.5 million in unpaid milestones will now be forgiven. Over the three years, LianBio has advanced mavacamten through clinical trials and, earlier this year, filed an IND in China, which will be reviewed under priority rules. The IND seeks approval of the drug to treat adults with symptomatic obstructive hypertrophic cardiomyopathy. San Francisco’s Aiolos Bio, a respiratory and inflammatory drug company, broke cover with $245 million in Series A funds and a Phase II asthma drug in-licensed from Jiangsu Hengrui Medicine (see story). In August, Aiolos, then known as One Bio, acquired rights to Hengrui’s asthma candidate, an anti-TSLP monoclonal antibody, for $21.5-million upfront and over $1 billion in milestones plus double-digit tiered royalties.Aiolos, a San Francisco-London company, plans to start a Phase II clinical trial of the TSLP mAb in moderate-to-severe asthma patients while it considers additional acquisitions. Shanghai Henlius Biotech out-licensed Europe/India rights for its anti-PD-1, Hansizhuang (serplulimab injection), to its partner, Intas Pharmaceuticals, in a $200 million deal (see story). Intas will have development and commercialization rights to the drug for several indications including ES-SCLC and for a specific formulation of the drug.Henlius will be responsible for clinical development and manufacturing of the candidate. Intas will make a $45 million payment upfront, up to $46 million in regulatory milestones, and $106 million in sales milestones, plus double-digit royalties on net profit. Sirius Therapeutics closed a $60 million Series-B financing to advance clinical development of the company’s novel siRNA therapeutics for cardiovascular needs (see story). It will also continue development of next-gen RNA delivery technologies. The company believes RNAi medicines offer an expanded range of drug targets with durable efficacy that could address existing unmet needs. Sirius has a Research Center in San Diego and a Translational Center in Shanghai. The B round, which included China-associated investors, was led by Hankang Capital. In its two fundings, Sirius has raised nearly $100 million. Angitia Biopharmaceuticals, a Guangzhou and Woodland Hills, CA company, closed a $46 million Series B extension for its breakthrough therapies that address unmet needs in patients with serious musculoskeletal diseases (see story). Angitia’s lead drug is AGA111, which is currently in a China Phase III trial to improve results of lumbar interbody fusions for degenerative disc disease.Altogether, the company has now raised $170 million. The funding was led by Morningside Group and included 3H Health Investment, OrbiMed, Yonghua Capital, Legend Capital, Oriza Holdings, and Elikon Venture.
Trials and Approvals
Sichuan Kelun-Biotech reported positive results at the 2023 ESMO conference from a China Phase II trial of its TROP2-ADC as a second-line therapy for patients with HR+/HER2- metastatic breast cancer (see story). SKB264 produced an objective response rate (ORR) of 36.8%, a disease control rate (DCR) of 89.5%, and a six-month duration of response (DoR) rate of 80%.In 2022, Kelun-Biotech partnered SKB264 with Merck (MRK) in a $1.4 billion agreement. It was the first of three deals the two companies signed last year with a total value of $12 billion. AnHeart Therapeutics, a New York-Shanghai biopharma, reported its next-gen ROS1 inhibitor shrank tumors in 92% of treatment-naïve patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) (see story). The interim data was collected from a global pivotal Phase II trial of taletrectinib. Taletrectinib also showed intracranial activity in 62% of patients whose disease had spread to the brain.Taletrectinib is an oral, brain penetrant ROS1 inhibitor. Median progression-free survival has not been reached for TKI naïve patients. According to AnHeart, patients with ROS1 NSCLC do not respond well to available TKI drugs, creating an un-met need.Virion Therapeutics and its JV partner, Ocean Biomedical (OCEA), have begun a Phase 1b clinical trial of VRON-0200 in Hong Kong and New Zealand (see story). An immunotherapy, VRON-0200 aims to be a functional cure for patients with chronic Hepatitis B virus (HBV) infection by overcoming immune exhaustion.VRON-0200 is a first-in-class treatment based on a Virion proprietary checkpoint modifier that is designed to broaden a patient’s own immune response. Virion, a Philadelphia biotech, develops novel T cell-based immunotherapies, while Ocean Bio of Providence, RI, accelerates novel drug candidates from academic and company researchers into approved drugs. More By This Author:Week In Review: China’s Biopharmas Announce $2.5 Billion In DealsWeek In Review: Two China Biopharmas Announce Billion Dollar DealsWeek In Review: QYuns Plans Hong Kong IPO For Autoimmune/Allergic Disease Portfolio