Deals and Financings
I-Mab (IMAB), a Shanghai biotech, raised $104 million in its IPO on the NASDAQ exchange to support its portfolio of more than ten biologic products (see story). I-Mab was founded in 2016 by C-Bridge Capital and Tasly Pharma, which merged two China companies, Third Venture Biotech and Tasgen Bio, and invested $150 million in newly formed I-Mab. The offering was priced at $14 per ADS, the middle of the expected range, but the price has moved 10% lower to $12.58 in initial trading.
BeiGene (NASDAQ:BGNE) of Beijing acquired China rights for two orphan biologic products, Sylvant® and Qarziba®, from EUSA Pharma in a $160 million deal (see story). Sylvant is approved to treat Castleman’s disease, a rare, life-threatening orphan condition of the lymph nodes. Qarziba is a targeted immunotherapy for neuroblastoma, an aggressive neoplasm that is the most common childhood solid tumor originating outside the brain. Both products are approved in various Western countries. They have been listed for fast-track approval in China because they target rare diseases that have no current treatments.
Suzhou Innovent Biologics (HK: 01801) out-licensed US-Canada rights for its Avastin biosimilar to Coherus BioSciences (NASDAQ:CHRS) (see story). Coherus will pay $45 million in upfront and milestone payments, plus double-digit royalties. Coherus is a Redwood City, California, biopharma that develops its own biosimilars and in-licenses others. Coherus also has a non-exclusive option to license US-Canada rights to Innovent’s Rituxan® biosimilar. Innovent cited Coherus’ successful US launch of UDENYCA, a biosimilar to Amgen’s Neupogen, as its reason for partnering with Coherus.
Sino Biopharma (HK: 1177) of Beijing partnered with San Diego’s Ambrx to develop two new Ambrx-discovered biologic products for cancer. Sino Bio will make an unspecified upfront payment to Ambrx and will also be responsible for developing the products to IND. Ambrx is eligible to receive additional milestone payments and tiered royalties on sales. Sino Bio will have rights to develop the products in China. Ambrx discovers next-gen biologics using its Protein Medicinal Chemistry platform to develop long-acting proteins, bi-specifics and antibody drug conjugates. Additional details were not released.
WuXi Biologics (HK: 2269) signed a long-term lease for a German biologics manufacturing plant owned by Bayer AG (OTCPK:BAYZF). WuXi will also purchase the facility’s equipment from Bayer and provide back-up manufacturing for its Kovaltry™, a recombinant treatment for Hemophilia Factor A. In 2018, WuXi Biologics released plans to spend $800 million to build four biologics manufacturing facilities around the globe, including a $395 million facility in Ireland that was expected to be the company’s first European manufacturing site.
Shenzhen Tisenc Medical Equipment, a China point-of-care testing company, completed a $12 million Series B round led by Feifan Shulian and Taifu Capital. Founded in 2015, Tisenc is a China-foreign JV that offers single-use point-of-care automatic chemiluminescence (CLIA) analyzers and more than 100 matching in-vitro diagnostic reagents. The company says its innovative ACCRE system can serve in emergency departments, STAT laboratories and core laboratories. Tisenc will use the proceeds of the funding to advance its R&D, increase production capacity and expand global marketing.
HitGen, a Chengdu drug discovery company, will collaborate with Kymera Therapeutics of Cambridge, Massachusetts, to identify small molecule leads for Kymera targets. Kymera is developing drug candidates that cause protein degradation to treat disease. Its goal is to use the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. HitGen will apply its DNA-encoded libraries (DEL) to discover compounds that bind to Kymera targets. Kymera will own the rights to the compounds. HitGen will receive an undisclosed upfront payment from Kymera and be eligible for milestone payments.
Trials and Approvals
Roche (OTCQX:RHHBY) announced that Alecensa (alectinib), the company’s ALK blocker, was approved in China as a first-line therapy for ALK-positive non small cell lung cancer (NSCLC) patients. Alecensa is an oral drug that blocks the activity of anaplastic lymphoma kinase (ALK). The approval was based on Roche’s global Phase III trial that compared Alecensa to the previous standard of care, a Pfizer (NYSE:PFE) drug, Xalkori (crizotinib). Alecensa, which has been available in the US and Europe for several years, increased progression-free survival to 34.8 months from 10.9 months for crizotinib.
Suzhou Innovent Biologics (HK: 01801) reported its PD-1 drug met a predefined progression-free survival endpoint in a China Phase III non-small cell lung cancer trial. Innovent said the data was consistent with an earlier stage trial. One year ago, Innovent announced Tyvyt produced an 68% objective response rate and an 11.4-month median progression-free survival in a similar Phase I test. In the Phase III trial, Innovent tested Tyvyt in combination with chemotherapy and platinum in first-line nonsquamous non-small cell lung cancer, without sensitive EGFR mutation or ALK rearrangement.
Hutchison China MediTech (Chi-Med) (NASDAQ:HCM) started a China Phase II trial of surufatinib in combination with Tuoyi, Shanghai Junshi Bio’s approved PD-1 drug, in patients with advanced solid tumors. Surufatinib is an oral anti-angiogenesis VEGFR inhibitor that also inhibits colony stimulating factor-1 receptor (CSF-1R), promoting a macrophage immune response. In June 2019, Chi-Med stopped a Phase III test of surufatinib early because it met its progression-free survival endpoint in patients with neuroendocrine tumors.
Government and Regulatory
The Phase I trade agreement between the US and China contains several important rules that are important for novel biopharma companies, with China agreeing to new rules for resolving pharmaceutical patent disputes, patent term extension and counterfeit medicines. China will warn patent holders when a generic pharma seeks regulatory approval for generic or biosimilar versions of a patent-protected drug, and to do so while the patent holder has time to respond. The agreement also contains six pages of rules for resolving disputes. The agreement does not, however, specify how long novel drugs will be protected by patents.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.