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Week in Review: BlissBio Announces Potential $2 Billion Deal with Eisai for HER2 ADC
Deals and Financings
Bliss Biopharma (Hangzhou), a clinical-stage ADC company, may out-license global rights (ex-China) for its HER2 ADC to Japan’s Eisai Pharma in a deal with a potential value of $2 billion (see story). Initially, the two companies are collaborating on conducting Phase I/II clinical trials of the candidate, an eribulin-payload based ADC aimed at HER2 to treat cancers. Longer-term, Eisai holds an option to acquire rights to the drug, which would trigger the upfront and milestone payments. The HER2 ADC area is hot: four years ago, AstraZeneca in-licensed Daiichi Sankyo’s HER2 ADC candidate for $1 billion in staged upfront payments.
Shanghai Junshi Bio (HK: 1877; SHA: 688180) out-licensed regional rights for its anti-PD-1 mAb to India’s Dr. Reddy’s Labs in a deal worth up to $728 million (see story). Junshi’s toripalimab is approved for six indications in China. Dr. Reddy’s will own rights to the drug in Latin America, India and South Africa, with potential to add Australia, New Zealand and nine other countries. The company also bought an exclusive right of first negotiation for commercialization of two other Junshi products. Junshi is testing toripalimab, the first domestic anti-PD-1 mAb approved for commercialization in China, for 15 indications globally.
Suzhou Zion Pharma out-licensed ex-China global rights for its lead HER2 candidate to Roche in a $680 million agreement ($70 million upfront) (see story). ZN-A-1041 is an oral selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2) that was designed to penetrate the blood-brain-barrier. Up to 50% of patients with HER2-positive metastatic breast cancer will develop brain metastasis over the course of the disease. Zion is conducting a Phase 1 trial of the candidate in China and the US, with trial details expected at the poster sessions during the ASCO meeting next month.
Hangzhou Chance Pharma entered a deal worth up to $144 million to commercialize Acorda’s inhaled therapy for Parkinson’s disease in Greater China (see story). In the US, Inbrija is approved as an intermittent treatment for episodic motor fluctuations (OFF episodes) in adult Parkinson's disease patients who are being treated with a levodopa/dopa-decarboxylase inhibitor. Chance, which will be responsible for China regulatory approval, will make up-front and milestone payments of $11.5 million plus up to $132.5 million in sales milestones. China has the world’s largest population of patients with Parkinson’s.
Guangzhou Reforgene Biotechnology closed a $15 million Pre-B financing for its portfolio of gene editing candidates, including a clinical stage therapy for thalassemia (see story). In a Phase I trial, the company’s lead β-thalassemia gene-editing drug, RM-001, produced a 100% cure rate. In addition, Reforgene is developing in vivo gene editing therapies for major genetic diseases in the fields of ophthalmology, nervous system and other fields. The financing was led by Yuexiu Industrial Fund with participation by Yuanyin Venture Capital, Shanfeng Venture Capital, Xinxing Fund, Hong Kong and Guangdong Capital, and Guoju Venture Capital.
Trials and Approvals
Shanghai LianBio (NSDQ: LIAN) announced that Camzyos® (mavacamten), its therapy for obstructive hypertrophic cardiomyopathy (oHCM), has been approved to launch in Macau (see story). It is the first approval for LianBio, which was formed to bring innovative drugs to China. Last month, LianBio reported positive topline results from a China Phase III for mavacamten in patients with symptomatic oHCM. China’s NMPA will review the drug under Priority rules. In 2020, LianBio in-licensed China rights to the drug from MyoKardia in a $187.5 million agreement.
Suzhou Innovent Biologics (HK: 01801) reported that a high dose (9 mg) of mazdutide produced a mean weight loss of 15.4% in obese China patients who were treated for 24 weeks in a Phase II trial (see story). Innovent acquired China rights to the drug, a dual GLP-1R and GCGR agonist, from its US partner, Lilly. Mazdutide is a mammalian oxyntomodulin (OXM) analogue designed to treat type 2 diabetes. It promotes insulin secretion, lowers blood glucose and reduces body weight, while it may also increase energy expenditure and improve hepatic fat metabolism by activating the glucagon receptor.
Suzhou GenAssist Therapeutic reported the US FDA accepted an IND for its novel in vivo gene editing candidate as a treatment for Duchenne muscular dystrophy (DMD) (see story). GEN6050 is a base editing drug that is designed to restore the expression of dystrophin protein that is caused by exon 50 skipping in the DMD gene. GenAssist’s TAM BE (Targeted AID-based Mutagenesis) base editing technology was discovered by one of its Founders, Xing Chang, PhD, who now serves as the company’s CSO. DMD is a rare disease that occurs once per 4000 newborn boys. Exon 50 skipping can be used to treat 4% of DMD patients with large deletions.
EQRx (NSDQ: EQRX), a Cambridge, MA company, will change its business plan; the company will no longer in-license China-developed drugs for western markets, hoping to sell them at up to a 50% discount from the competition (see story). EQRx will return rights to CStone Pharma for sugemalimab (a PD-L1 candidate) and nofazinlimab (a PD-1 antibody), and it will also give back rights to a JAK1 inhibitor from Lynk Pharmaceuticals. The company’s business plan may have become infeasible when the US FDA refused to approve a China-developed PD-1 drug based only on China trial data. Lilly acquired the candidate from Suzhou Innovent.
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