Deals and Financings
Jiangxi Jemincare, a China pharma formed in 1999, out-licensed global rights for its androgen receptor degrader to Roche (OTCQX:RHHBY, OTCQX:RHHBF) in a $650 million agreement (see story). JMKX002992 is being developed to treat prostate cancer patients who have developed resistance to current therapies. The oral small-molecule candidate, which was developed in Shanghai Jemincare’s 500-scientist R&D center, is currently in preclinical testing. Jemincare will receive $60 million upfront and the rest in milestones, plus royalties. Roche said the agreement was the first global in-licensing between its Genentech subsidiary and a China biopharma. The deal was originally announced in August.
Shanghai IASO Biotherapeutics issued an exclusive worldwide license for a fully human CD19 binder to Philadelphia’s Cabaletta Bio (CABA) in a deal worth up to $162 million (see story). Cabaletta will use the binder in CABA-201, a CD19-targeting CAR T that aims to be one of the first curative targeted cell therapies for autoimmune diseases. IASO Bio will receive up to $162 million in upfront and milestone payments for two possible candidates, plus royalties. IASO Bio has first negotiation rights to develop and commercialize Cabaletta’s products in Greater China.
Harbour BioMed (HK: 02142) out-licensed Greater China rights for an autoimmune therapy to CSPC NBP Pharma in a deal worth up to $140 million, including $21 million upfront, plus royalties. NBP will be responsible for China clinical development, commercialization and manufacturing of batoclimab. The candidate is an anti-FcRn monoclonal antibody that accelerates the degradation of autoantibodies to treat pathogenic IgG-mediated autoimmune diseases. In 2017, Harbour acquired China rights to batoclimab in a two-candidate deal from Korea’s HanAll Biopharma for $81 million. Harbour has started a China Phase III trial for batoclimab in myasthenia gravis patients.
Shanghai WuXi Biologics (OTCPK:WXXWY, OTCPK:WXIBF, HK: 2269) and Toregem BioPharma, a Kyoto University biotech startup, signed a Memorandum of Understanding to partner development of TRG035, a monoclonal antibody targeting USAG-1 for congenital adentia. TRG035 is a tooth regeneration antibody drug based on the research results of Dr. Katsu Takahashi, Oral and Maxillofacial Surgery, Kyoto University. Although most adults have a full set of 32 teeth, about 1% of the population has more or fewer due to congenital conditions. USAG-1 is a bifunctional protein that antagonizes BMP and Wnt, two signaling molecules essential for tooth development.
Trials and Approvals
Shanghai JW Therapeutics (OTCPK:JWCTF, HK: 2126) reported that its CAR-T immunotherapy, relmacabtagene, was approved in China as a second-line treatment for follicular lymphoma (see story). The NMPA approved the anti-CD19 cell immunotherapy to treat adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment. One year ago, the candidate was approved in China as a third-line therapy for large B-cell lymphoma. JW is a joint venture formed by Seattle’s Juno Therapeutics, a cell therapy biotech, and WuXi AppTec (OTCPK:WUXIF, OTCPK:WUXAY), a China CRO/CMO.
Suzhou Innovent Bio (OTCPK:IVBIY, OTCPK:IVBXF, HK: 01801) was approved to launch selpercatinib, a RET kinase inhibitor in China for patients with cancers that involve rearranged during transfection (RET) gene fusions, a condition that occurs in 1-2% of NSCLC cases. Selpercatinib was discovered by Eli Lilly (LLY), an Innovent partner since 2015. Selpercatinib is a selective, potent RET kinase inhibitor with CNS activity that was approved for US use in May 2020. One month ago, the FDA granted selpercatinib second-line US approval for tumor-agnostic indications in adult patients with a RET gene fusion.
Beijing’s BeiGene (BGNE, HK: 06160, SHA: 688235) reported Europe’s CHMP recommended approval of its BTK inhibitor, Brukinsa (zanubrutinib), for chronic lymphocytic leukemia (CLL). BeiGene says it designed Brukinsa for improved results by optimizing bioavailability, half-life and selectivity. The CHMP recommendation is based on two global Phase III clinical trials that showed better efficacy and fewer side effects compared to current therapies. BeiGene is conducting 35 Brukinsa trials that have enrolled more than 4,500 subjects. It is approved in various countries for Waldenström’s macroglobulinemia, mantle cell lymphoma and marginal zone lymphoma.
Bio-Thera Solutions (SHA: 688177) of Guangzhou started a Phase I trial of its Nucala biosimilar in patients with asthma or one of two rare blood diseases. Mepolizumab is an interleukin-5 (IL-5) antagonist mAb that is administered subcutaneously. Currently, the approved drug is indicated as an add-on maintenance therapy for severe asthma patients with an eosinophilic phenotype and adult chronic rhinosinusitis patients with nasal polyposis. After the Phase I trial, Bio-Thera plans to run a global Phase III study and request approval for all indications in China, US and EU regulators.
Accutar Biotechnology, an AI-based New Jersey-Shanghai drug discovery company, has dosed the first patient in a China Phase I trial of AC0682, an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation. Accutar’s proprietary AI platform uses an innovative universal force field-based modeling methodology that reduces the average preclinical drug discovery time to one year. Earlier this year, the company started trials China of an AR degrader for prostate cancer.
LianBio (LIAN), a Princeton-Shanghai company, stopped a Phase III China trial of Truseltiq (infigratinib) following news that Switzerland’s Helsinn Healthcare will stop distributing the liver cancer drug in the US for “business reasons”. The company will request the FDA to withdraw the drug’s approval for cholangiocarcinoma, issued one year ago. Helsinn signed a $2.4 billion partnership deal with BridgeBio (BBIO) of the US to distribute the drug, while LianBio acquired greater China rights. LianBio will provide the drug to current China patients and continue a Phase IIa proof-of-concept study of Truseltiq for other indications.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.