adminDeals and Financings
Jiangsu Hengrui Pharma out-licensed global rights (ex-China) for its next-gen PARP1 inhibitor to Germany’s Merck KGaA (OTCPK:MKGAF) for a $170 million upfront payment and up to $1.5 billion in milestones, plus royalties (see story). Merck will have rights to manufacture and commercialize the drug. It will also have an option for exclusive global rights to manufacture and commercialize Hengrui’s Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. And Merck will own an option to co-promote both assets in China. Hengrui says next-gen PARP1 inhibitors offer better selectivity and safety, offering possible efficacy in new indications.
BioLineRx (BLRX), an Israeli biotech, out-licensed China rights to motixafortide, a stem cell mobilizer, to Guangzhou Gloria Biosciences in a $280 million agreement (see story). One month ago, BioLineRx was approved to launch Aphexda™ (motixafortide) in the US in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and autologous re-transplantation in multiple myeloma patients. It also plans to start trials of motixafortide in patients with sickle cell disease. In 2021, GloriaBio was approved for China marketing of YuTuo® (zimberelimab), a PD-1 inhibitor, for classical Hodgkin’s lymphoma.
AnHeart Therapeutics, a New York-Shanghai biopharma, sold Japanese rights for its lead drug, a ROS1 tyrosine kinase inhibitor to Nippon Kayaku (OTCPK:NPKYY) for $40 million upfront plus unspecified milestone and royalty payments (see story). Last week, AnHeart reported that taletrectinib, its next-gen ROS1 inhibitor, shrank tumors in 92% of treatment-naïve patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in a global Phase II trial. Nippon Kayaku will have rights to that indication along with others of its own choosing. AnHeart will continue taletrectinib trials for NSCLC and will supply the drug Nippon Kayaku for Japan commercialization.
Suzhou CStone Pharma (OTCPK:CSPHF, HK: 2616) out-licensed China rights for nofazinlimab, the company’s anti-PD-1 antibody, to a subsidiary of 3SBio (OTC:TRSBF, HK: 1530) for $8 million upfront and $14 million in near term milestones. CStone will also receive unspecified payments for sales milestones and royalties. 3SBio will have rights to develop, register, manufacture and commercialize nofazinlimab in mainland China. CStone expects to report results in Q1 of 2024 from a global Phase III trial of nofazinlimab plus lenvatinib as a first-line treatment for hepatocellular carcinoma (HCC). Yesterday, CStone’s anti-PD-1/PD-L1 drug, sugemalimab, was approved in China for extranodal NK/T-cell lymphoma.
Shenzhen Mellow Hope Pharm and Rational Vaccines (RVx) of Massachusetts have teamed up to jointly develop, manufacture and commercialize live vaccines for herpes simplex viruses (HSV-1 and HSV-2). There are no approved HSV vaccines anywhere in the world. Rational Vaccines develops rationally engineered, live attenuated viral immunotherapeutic and prophylactic vaccine candidates, with a focus on herpetic diseases. The two companies will use RVx’s proprietary virus mutants to develop the candidates. Mellow Hope supplies pharmaceuticals in China with a heavy emphasis on human vaccines – its portfolio includes 14 vaccines.
Trials and Approvals
Shanghai Junshi Bio (OTCPK:SHJBF, HK: 1877; SHA: 688180) and Coherus BioSciences (CHRS) announced the US FDA approved their partnered PD-1 drug, Loqtorzi™, to treat two relatively rare nasopharyngeal carcinoma indications without any US trials. In early 2022, the FDA refused to OK a PD-1 developed by Lilly and Suzhou Innovent because the IND’s trial data did not include any Caucasians. The rejection implied that China’s novel drugs could not be brought to the US based on China data. It seems the situation is more nuanced than previously thought, though the actual rules aren’t entirely clear.
Suzhou Innovent (HK: 01801) reported maxdutide, a GLP-1R/GCGR dual agonist, reduced body weight by 18.6% in obese patients after 48 weeks of treatment in a China Phase II trial. Innovent in-licensed Greater China rights to maxdutide from its long-term partner, Eli Lilly (LLY). Trial patients, who had moderate to severe obesity, received a high dose of 9mg. Besides the efficacy, maxdutide showed favorable safety and multiple metabolic benefits. Innovent plans to start a similar Phase III trial of the candidate before the end of the year. It is currently also conducting China trials at lower doses for obesity and type 2 diabetes.
HuidaGene Therapeutics, a Shanghai-New Jersey gene editing company, has dosed the first patient in a China-US Phase I/IIa clinical trial for inherited blindness caused by RPE65 mutations. HuidaGene develops CRISPR-based programmable genomic medicines. HG004 is an adeno-associated virus 9 (AAV9) gene replacement therapy candidate aimed at inherited retinal dystrophies. The candidate uses a recombinant AAV9 vector to deliver a functional human RPE65 gene to the retina to restore, treat, and prevent blindness of children and adults with RPE65-IRDs. HG004 has been granted both orphan drug and rare pediatric disease designations in the US.
Ractigen Therapeutics, a Jiangsu RNA activation (RNAa) company, presented preclinical results of its short duplex RNA (saRNA) technology to develop a gene therapy for Duchenne muscular dystrophy (DMD). The saRNA targets activation of utrophin to increase transcription of endogenous genes, leading to restoration of their protein function. The company says saRNA offers the possibility of modulating traditionally undruggable targets, one of the few technologies that can treat diseases by stimulating the expression of therapeutic genes with insufficient expression.
Shenzhen Chipscreen Biosciences (SHA: 688321) was approved to start China clinical trials of its novel oral therapy for psoriasis. CS32582 is a small molecule, selective allosteric inhibitor of Tyrosine Kinase 2 (TYK2) that was developed by Chipscreen. It specifically binds to its regulatory pseudokinase JH2 domain. Because it does not inhibit the JAK1, JAK2 and JAK3 members of the same family, CS32582 is expected to combine therapeutic efficacy with a favorable safety profile. Chipscreen said the candidate showed significant efficacy in mouse models of psoriasis.
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