Deals and Financings

Biotheus, a China biopharma based in Zhuhai, Guangdong, announced a $142 million agreement to in-license greater China rights for a TNFR antibody developed by Alligator Bio of Stockholm (NSDQ Stockholm: ATORX) (see story). Formed in 2018, Biotheus will have rights for up to three bi-specific candidates based on the antibody. The agreement, which specifies a $1 million upfront payment, will include a $90 million option for Biotheus to acquire global rights to the candidates. Biotheus is developing a pipeline of me-better/novel candidates focused on immuno-oncology and metabolic disease.

Yaoyanshe, a Shanghai on-line AI-based CRO/CMO, raised $42 million in a C funding round led by Eastern Bell Capital and Sequoia China (see story). Founded in 2015, Yaoyanshe offers Trial.Link, a repository of China clinical trial information that connects biopharmas, hospitals, researchers, industry practitioners and patients. The company says the platform currently includes more than 180 hospitals and 300 drug manufacturers. Yaoyanshe believes the platform shortens the timeline for clinical development by 20% and lowers development costs by 15%. In addition, the company is building a similar platform to cover China's drug R&D landscape.

Shenzhen Xpect Vision Technology closed a $14 million B financing to support development of its new imaging technologies (see story). Founded in 2015, Xpect considers itself a leader in photon-counting X-ray imaging along with other new technologies such as high-speed, high-definition imaging chips. The B round was led by Shenzhen Time Bole Venture Capital Investment. Besides its Shenzhen headquarters, Xpect has R&D facilities in Beijing and Shanghai.

Shenzhen's China Medical System (HK: 0867) acquired China rights to seven generic drugs from India's Sun Pharma (NSE: SUNPHARMA, BSE: 524715) (see story). The seven drugs were not identified, but Sun said they have China market revenues of $1 billion annually. Two months ago, CMS in-licensed two other Sun products, a treatment for dry eye and a biologic treatment for psoriasis. Sun Pharma is one of several Indian drug companies that are now bringing their products to China, usually by forming relationships with China companies. The financial details of the agreement were not disclosed.

Suzhou Innovent Bio (HKEX: 01801) in-licensed China rights to a novel treatment for type 2 diabetes from Eli Lilly (NYSE: LLY) (see story). In 2015, Innovent and Lilly established a $1 billion collaboration to co-develop several Innovent cancer therapeutics, including its China-approved PD-1 drug, Tyvyt®. The Lilly diabetes candidate, an oxyntomodulin analog known as OXM3, is a dual GLP-1 and glucagon receptor agonist. Lilly believes the drug also causes significant weight loss. The two companies plan to develop OXM3 as a therapy for diabetes, obesity and potentially nonalcoholic steatohepatitis (NASH).

Suzhou Kintor Pharmaceuticals signed a cooperation agreement with CMAB Biopharma (Suzhou), a biologics CDMO, to develop and manufacture Kintor's ALK-1 mAb (see story). Kintor in-licensed global rights to the candidate from Pfizer (NYSE: PFE), which previously conducted two Phase I trials of the molecule. In the trials, ALK-1 mAb demonstrated a favorable PK and safety profile and reasonable clinical benefits. Kintor says the data suggests the novel antibody, an anti-angiogenesis molecule, has the potential for approval, a first-in-class drug for ALK-1.

LHHC Medical Technology, a China AI company, announced a global cooperation with Vancouver's Enlighta (TSXV:NLTA) to market LHHC's early cancer detection test (see story). The "No Cancer" technology combines LHHC's AI data models and algorithm with conventional blood test data, specifically for individuals of Chinese and Asian ancestry. It assesses an individual's risk of developing any one of thirteen early-stage cancers, allowing early prevention and intervention. The test, which aims to identify any immunological abnormalities, has an 85% accuracy, said LHHC. LHHC was formed by scientists from well-known China universities.

Trials and Approvals

Suzhou's CStone Pharma (HK: 2616) has been approved to start an Australian Phase I clinical trial of its CDK4/6 inhibitor as a treatment for solid tumor cancers (see story). CS3002 is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6), a mechanism that is thought to induce the cell cycle arrest of tumor cells. CStone said preclinical tests have shown CS3002 to have potential efficacy in combination with endocrine therapy or immune checkpoint inhibitor therapies. The company expects to start a Phase I trial of the candidate in China before the end of 2019.

Luye Pharma (HK: 2186) of Yantai has been approved to start Japan trials of its novel treatment for depression, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) in extended release tablet form (see story). Ansofaxine Hydrochloride ER Tablets (LY03005) has already begun Phase III trials for LY03005 in China and the US. Luye expects LY03005 will avoid the side-effects of serotonin-only treatments for depression. The candidate is part of Luye's larger effort to expand its portfolio of central nervous system drugs.

Abbisko Therapeutics, a Shanghai clinical-stage biopharma, received approval to begin a US Phase I trial for ABSK021, a small molecule CSF-1R inhibitor (see story). By inhibiting CSF-1R, ABSK021 is expected to reprogram tumor-associated macrophages (TAMs) and other immune cells and limit tumor immunosuppression. Abbisko, which discovered the candidate and owns full intellectual property rights globally, believes ABSK021 may prove to be a best-in-class drug. The Phase I trial will test ABSK021 in patients with advanced malignancies and Tenosynovial Giant Cell Tumors (TGCT).

Government and Regulatory

China has added 148 drugs to its list of medicines covered by basic medical insurance plans, the first update in two years (see story). The additions were comprised of 47 western drugs and 101 TCM products, including medicines for cancers, rare diseases, chronic diseases and children’s diseases, as well as some basic drugs. Still unfinished is an additional list that includes expensive drugs of high clinical value, the new therapies for cancer and other medications. These drugs require price negotiations with drug pharmas over the China cost of the products, particularly for western biopharma companies.

Disclosure: none.