Week In Review: Henlius Out-Licenses Southeast Asia Rights For PD-1 Candidate In $692 Million Deal

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Deals and Financings

Shanghai Henlius Biotech (HK:2696) announced a $692 million partnership with Kalbe Genexine Biologics for Southeast Asian rights to Henlius’ PD-1 checkpoint inhibitor (see story). Kalbe Genexine is a JV formed by Kalbe Farma of Indonesia and Genexine of South Korea. Henlius, the biologics arm of Fosun Pharma (SHA:600196) (HK:2196), will receive $10 million upfront, $22 million in regulatory milestones, $650 million in commercial milestones and $10 million for combination trials. Last week, Henlius completed a $410 million IPO on the Hong Kong Exchange.

Blue Sail Medical (SHZ:2382) of Shandong and Biosensors, a subsidiary of Blue Sail, will pay $160 million to acquire New Valve Technology, a Swiss medical device company. NVT specializes in safe, cost-effective, minimally invasive heart valve replacements. Its Allegra transcatheter aortic valve replacement device was approved in the EU in 2017. Blue Sail is known primarily for its disposable medical/surgical PVC gloves, while its Biosensors subsidiary, located in Singapore, makes stents, a complementary market to NVT’s products.

Qihan Biotech of Hangzhou added $5.5 million to its Series A funding, bringing the total to $25.5 million. The company will use the funds to advance its use of CRISPR Cas-9 gene editing for xenotransplantation, the use of animal organs as transplants. In July, the company announced a $20 million funding that has now expanded. Qihan, which was founded in November 2017 as an offshoot of US-based eGenesis, plans to grow organs in pigs because human donor organs are in short supply.

Guanhao Biotech of Guangzhou will pay $3.1 million to acquire a 31% stake in ZY Therapeutics, a North Carolina company. ZY Therapeutics is focused on nanotech drug delivery. The company, which is developing a lyophilized cancer drug, is based on the premise that many drugs do not achieve their full therapeutic potential because they lack a controllable, targeted delivery. Guanhao is a regenerative medicine company that produces animal-sourced dura patches that is now expanding into drug development.

Changmugu, a Beijing AI-based orthopedics company, completed a $3 million Pre-A round. The company, which claims to have developed the world’s first three-dimensional artificial joint replacement surgery planning system, uses AI to improve the entire process of joint replacements, including pre-op evaluation, surgical planning, 3D printing and individualized surgical navigation guidance. Changmugu will use the capital to expand its AI orthopedic products, advance the clinical registration process and support clinical use of its products. The round was led by Legend Star and joined by Frees Fund and Wanhui Capital.

China National Biotec Group (CNBG), a Sinopharm subsidiary, acquired China rights to an aesthetic gel implant from Boston’s Advanced Aesthetic Technologies (AAT) after making an equity investment in AAT. CNBG described the investment as a major but non-controlling stake. A CNBG subsidiary, Lanzhou Biotechnique Development, will be responsible for China regulatory approvals and for distributing Algeness®, the AAT gel product, in mainland China. Through Lanzhou, CNBG is the sole producer of botulinum toxin in China; its Hengli® (LANTOX) dominates the market with a 75% share.

Xi ‘an Zhentai Intelligent Technology completed an angel funding round to develop its rehabilitation robot technology that includes a brain-computer interface. Lenovo Capital was the only investor. Incubated at Xi’an Jiaotong University, ZhenTec combines expertise in the brain-computer interface, AI and virtual reality to develop rehabilitation devices for assisted walking. The company’s devices are aimed at patients with ALS, stroke, spinal cord injury and other neurological dysfunction.

Simcere, a Nanjing pharma, in-licensed greater China rights to a treatment for gout from JW Pharmaceutical (KRX:001060) of Korea. URC-102, a selective inhibitor of uric acid transporter (URAT-1), is currently in a South Korean Phase IIb clinical trial. According to the companies, current treatments for gout are prone to adverse effects and not always effective. Simcere will be responsible for the clinical research, registration and commercialization of URC-102 in China, Hong Kong and Macau. JWP will receive an upfront payment, milestones and China royalties, though specific details were not disclosed.

Nanjing Frontier Bio will collaborate with Thermo Fisher Scientific (NYSE:TMO) to develop a novel treatment for human immunodeficiency virus (HIV), providing clinical trial supplies of the candidate (see story). Frontier already has a China approved treatment for HIV, albuvirtide, but it is developing a second HIV treatment that it in-licensed from the Rockefeller University of New York City. Frontier’s drug development is centered on a long-acting peptide platform designed to transform any peptide drug into a long-acting agent.

Trials and Approvals

I-Mab, a China-US clinical-stage biopharma, announced a clinical research collaboration with MSD (Merck (NYSE:MRK)) to test a combination of I-Mab’s anti-CD47 mAb and MSD’s PD-1 therapy, Keytruda® in multiple types of cancer (see story). The two companies will work together to develop a protocol for a Phase 1 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination. MSD will supply Keytruda® to I-Mab for the trial. I-Mab focuses on immuno-oncology and autoimmune therapies.

Shanghai’s CARsgen Therapeutics received PRIority MEdicine status in the EU for its anti-BCMA CAR-T cell therapy (CT053) as a treatment for relapsed or refractory multiple myeloma. In a China Phase I trial of CT053, 21 out of 24 myeloma patients (87.5%) experienced an objective response and 19 out of 24 patients (79.2%) achieved a complete response. The patients had received an average of 4.5 prior treatments. There was no cytokine release syndrome of grade 3 or higher. CARsgen will report the duration of response at a later date.

CStone Pharma (HK:2616) of Suzhou reported early results from a China trial of its PD-L1 candidate at the recent Chinese Society of Clinical Oncology meeting. In a Phase Ib study, CS1001 produced a 38% overall response rate in patients with microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) solid tumors who had been heavily pre-treated. CStone said MSI-H/dMMR is common in patients with endometrial cancer, gastric adenocarcinoma, malignant small intestine tumor and colorectal adenocarcinoma. In the trial, most patients had colorectal cancer.

Disclosure: None

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Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.

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