COVID-19 Pandemic

BioKangtai (SHZ: 300601), a Guangdong vaccine company, in-licensed rights to develop, manufacture and market AstraZeneca's (NYSE: AZN) COVID-19 vaccine in China (see story). The candidate is an adenovirus vector-based COVID-19 vaccine that was created by Oxford University and partnered by AstraZeneca. Financial details of the China deal were not disclosed, but BioKangtai did promise to make at least 100 million doses of the vaccine by the end of 2020 and 200 million doses per year by the end of 2021.

Shanghai Fosun Pharma (SHA: 600196; HK; 02196) reported it has dosed the first 72 participants in a China Phase I trial of an mRNA vaccine for COVID-19 (see story). The initial phase of the trial enrolled healthy adults aged 18 to 55 years; the second phase will enroll 72 individuals who are over 55 . In March, Fosun in-licensed Greater China rights to the vaccine from BioNTech (NSDQ: NVTX) of Germany in a $135 million deal. Pfizer partnered the ex-China rights to the candidate with BioNTech and plans to start a global Phase IIb/III trial soon.

Deals and Financings

Biogen (NSDQ: BIIB) announced a $2 billion blockbuster deal to partner Denali Therapeutics' (NSDQ: DNLI) potential Parkinson's Disease therapy (see story). In exchange for its $1 billion in upfront payments and $1 billion in milestones, Biogen will have rights to partner commercialization of Denali's small molecule LRRK2 inhibitors in the US and China, plus exclusive rights in the rest of the world. The agreement underscores that Denali, a South San Francisco company, considers China's market a significant factor in global marketing plans of its Parkinson's candidate.

Sherpa Healthcare Partners of Beijing closed its first US dollar fund with $200 million in capital, which Sherpa said was oversubscribed (see story). The Oregon Public Employees Retirement System (PERS) committed $100 million of the total. Sherpa will focus on early- to growth-stage investments in biotech, biopharma, medical device and medical service companies in both China and the US. It has already completed investments in eight life science companies.

Lepu Biotech of Shanghai closed a $186 million Series B round to support its portfolio of affordable cancer immunotherapies (see story) Lepu Bio, a subsidiary of China medical device company Lepu Medical, was founded in 2018. It has built a pipeline of 12 candidates including seven that have started clinical trials. Lepu's clinical-stage products include PD-1, PD-L1, oncolytic virus and multiple antibody drug conjugate candidates. The B Round was led by the investment arms of Ping An Insurance and Sunshine Insurance.

Nanjing Simcere Pharma in-licensed Greater China rights to trilaciclib from North Carolina's GI Therapeutics (NSDQ: GTHX) in a $170 million agreement (see story). Trilaciclib is a proposed myelopreservation therapy intended to improve chemotherapy treatment. Simcere will make a $14 million upfront payment and add up to $154 million in milestone payments, plus royalties. Trilaciclib has been granted US Breakthrough Therapy Designation following three double-blind trials in which it was administered before chemotherapy to patients with small cell lung cancer.

ABM Therapeutics of Shanghai completed a $20 million Series A+ round (see story). Founded in 2015, ABM develops small molecule drugs that cross the blood-brain barrier. The company has one candidate, ABM-1310, in clinical trials for glioblastoma along with several preclinical projects that are designed to cross the blood-brain barrier and treat brain metastasis from melanoma, lung and breast cancer. The A+ round was led by Huachuang Capital.

VistaGen (NSDQ: VTGN) of South San Francisco announced that Shanghai's EverInsight completed payment of a $5 million license fee for rights to its novel treatment for social anxiety disorder (SAD) in China and other Asian countries (see story). EverInsight will be responsible for Asia development of PH94B, a rapid-onset neuroactive nasal spray. The $5 million upfront payment was part of a $177 million package agreed to by the companies that also included milestone payments, plus royalties. ChinaBio® advised VistaGen on the transaction.

Trials and Approvals

CStone Pharma (HK: 2616) announced CS1001, an anti-PD-L1 mAb, met its primary progression-free survival endpoint at an interim analysis in a China Phase III trial (see story). CS1001 was tested as a first-line treatment of stage IV squamous and non-squamous NSCLC. It was administered in combination with platinum-based chemotherapy and compared to platinum chemotherapy alone The median PFS was 7.8 months in the CS1001 cohort compared to 4.9 months in the control group. Based on the trial, the company plans to file an NDA in China soon.

NeuPharma of Suzhou BioBay has started a Phase II trial RX108 in patients with recurrent glioblastoma multiforme (GBM) (see story). Two weeks ago, the company began a similar trial of the same candidate in patients with head and neck squamous cell carcinoma (HNSCC). RX108 is a novel small-molecule inhibitor of sodium-potassium adenosine triphosphatase (Na+/K+-ATPase). It is currently being tested in several clinical trials in China and the US for various types of cancer.

Zai Lab (NSDQ: ZLAB) of Shanghai said China's NMPA granted priority review to its ripretinib NDA as a treatment for advanced gastrointestinal stromal tumor (GIST) (see story). In 2019, Zai in-licensed rights to candidate in a $205 million deal from Deciphera Pharma of Massachusetts. Two months ago, Deciphera (NSDQ: DCPH) was approved to market ripretinib in the US for the same indication. Ripretinib targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.

Suzhou Innovent (HK: 01801) dosed the first patient in a China Phase I clinical trial of its anti-CD47/PD-L1 bispecific antibody in patients with advanced malignancies (see story). The trial is designed to evaluate the safety, tolerability and initial anti-tumor efficacy of IBI322 in patients with lung, cervical, esophageal, head and neck squamous cell and liver carcinomas who have failed standard therapy. IBI322, which has the potential to be a first-in-class drug, is approved to start testing in both the US and China.

Disclosure: none.