Week In Review: Zai Lab Enters $338 Million Agreement To In-License KRAS Inhibitor

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Deals and Financings

  • Shanghai's Zai Lab (ZLAB) in-licensed Greater China rights to adagrasib, a KRASG12C inhibitor, from Mirati (MRTX) of San Diego in a $338 million agreement (see story). Mirati will receive a $65 million upfront payment and up to $273 million in milestones, plus royalties. Mirati has registration-enabling studies of the candidate underway in NSCLC and colorectal cancer. Last week, Amgen (AMGN) was approved for US launch of its KRAS inhibitor, a target that was once considered un-druggable.  
  • The Guangzhou government is raising $300 million from Guangzhou institutions for the Guangzhou Sino-Israel Biotech Investment Fund’s (GIBF) second fund (see story). Shuki Gleitman, the former chief scientist of the Israel Ministry of Industry and Trade, is a partner with Guangzhou. The first fund raised $100 million for Israeli medical device companies. The fund helped its portfolio companies to found China subsidiaries, which carried out clinical trials in China. In the new fund, GIBF will invest $15-$20 million in each biomedical company.  
  • Shanghai's Stemirna Therapeutics raised nearly $200 million to finance clinical trials and production of its messenger RNA COVID-19 vaccine candidate (see story). The company, located in Zhangjiang Hi-Tech Park, develops immunoncology and infectious disease products using its mRNA technology. It expects its COVID-19 vaccine candidate, which has already started a Phase II trial, will be effective against the South Africa, Brazil, and India variants. The financing was led by China Merchants Group's health sector investment arm, Sequoia Capital China and WuXi AppTec.  
  • Suzhou Innovent Biologics (1801.HK) acquired China rights to co-develop and commercialize taletrectinib, an AnHeart oncology treatment, in a $189 million pact (see story). Taletrectinib as a next-gen TKI that targets ROS1 and NTRK. AnHeart, a Hangzhou company, is already conducting two Phase II trials of  taletrectinib in China, one in NSCLC and the other in solid tumors, plus a global Phase II trial in NSCLC. Patients with ROS1 and NTRK positive NSCLC acquire resistance to existing treatments.  
  • LianBio acquired China rights to a long-term treatment for chronic rhinosinusitis (CRS) from Lyra Therapeutics (LYRA) in an agreement worth up to $147 million (see story). LYR-210 combines a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex to provide six-months of therapy. Lyra positions the product, which is in late-stage trials, as an alternative to surgery for people with CRS who do not respond to other drugs. Formed last year, LianBio is a China in-licensing company that is headquartered in Shanghai and Princeton.  
  • Phanes Therapeutics, a San Diego-Shanghai immunoncology company, completed a $40 million Series B financing (see story). The company is developing a pipeline of seven mAb and bi-specific pre-clinical candidates that it discovered using its two technology platforms. The B round was led by Sequoia Capital China. Phanes said it would use the proceeds to advance several pre-clinical programs into the clinic, expand its research and clinical teams, and advance new research projects.  
  • Neurophth, a Wuhan company developing gene therapies for ophthalmic diseases, will partner with Hangzhou's Hopstem Biotech to develop a candidate using stem cells for ocular diseases including blindness (see story). Hopstem has expertise in GMP manufacturing of clinical cell products derived from human induced pluripotent stem cells (hiPSC). It will receive upfront and milestone payments, plus royalties, to develop a candidate for a specific retinal degenerative disorder. Neurophth, which will have the option to license the candidate, will be responsible for its development and commercialization.  

Government and Regulatory 

In late May, Shanghai's municipal government announced a set of cash incentives for Shanghai companies that are developing new drugs, medical devices, or signing contract manufacturing agreements (see story). Shanghai will underwrite 40% of a novel drug's R&D expenses if the drug qualifies for China 1.1 status (candidates never approved anywhere).

In addition, other new biologics will receive up to $1.5 million and chemical drugs $500,000, while new TCM therapies will be eligible for up to $4.5 million. The plan was originally described by Brian Yang of Pink Sheet (see article), who generously allowed ChinaBio to use the information.  

Trials and Approvals 

  • Suzhou Innovent Biologics and its partner, Eli Lilly (LLY), announced their jointly developed anti-PD-1 was approved in China as a first-line therapy for NSCLC (see story). China approved Tyvyt® (sintilimab injection) in combination with gemcitabine and platinum chemotherapy as a first-line therapy for locally advanced or metastatic squamous non-small cell lung cancer. It is the third China approval for Tyvyt. Previously, Tyvyt was approved for classical Hodgkin's lymphoma and nonsquamous non-small cell lung cancer.  
  • MicuRx Pharma was approved for China commercialization of contezolid, its next-gen oxazolidinone antibiotic, to treat complicated skin and soft tissue infection (see story). MicuRx has completed nine contezolid clinical trials both in and outside of China showing efficacy in treating infections caused by multi-drug resistant gram-positive bacteria, while reducing the myelosuppression side effects or inducing drug resistance. Initially, MicuRx will launch contezolid in China while it conducts additional trials in the US. It will be the first MicuRx product to be commercialized.  
  • Shanghai Junshi Bio (1877.HK) reported toripalimab, the company's anti-PD-1 drug, was effective as a first-line treatment for nasopharyngeal carcinoma (see story). In a China Phase III trial, a combination of toripalimab plus chemotherapy met its pre-specified endpoint of progression-free survival in an interim analysis. In 2018, toripalimab was approved in China as a second-line therapy for melanoma, the first China-developed anti-PD-1 mAb authorized for launch. Earlier this year, Coherus Bio entered a $1.1 billion agreement with Junshi for US-Canada rights to toripalimab.  
  • Nanjing IASO Bio has been approved to start China clinical trials of CT120, its second CAR-T candidate to enter clinical trials (see story). The company will test its fully human CD19/CD22 dual-targeting chimeric antigen receptor-T cell therapy in patients with relapsed/refractory B-acute lymphoblastic leukemia. Two years ago, IASO and its partner, Suzhou Innovent, started a Phase Ib/II trial of their jointly developed lentiviral vector/CAR-T candidate, which is designed to treat multiple myeloma patients who have progressed after an earlier CAR-T treatment.  

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