Leo Pharma, a Denmark dermatology company, acquired global rights to a novel treatment for atopic dermatitis (AD) and allergic asthma in an agreement worth up to $570 million (see story). FB825 is a first-in-class candidate that targets the CεmX domain of membrane-bound IgE (mIgE), causing a depletion of mIgE positive B-cells and slowing the immune response, the company said. Leo acquired FB825 from Oneness Biotech (TPEx: 4743) of Taiwan and Microbio Shanghai. It made a $40 million upfront payment and will pay up to $530 million of milestones, plus royalties.

Beijing Mabworks Biotech raised $160 million in a Series C1/C2 funding to support its biologic drug development efforts (see story). Founded in 2011, Mabworks has more than 15 candidates being tested in China and US trials targeting diseases that include lung, breast and colorectal cancers, leukemia and infectious diseases. The company has partnered with InnoCare Pharma to develop a novel therapy for B-cell lymphoma, and it also collaborates with China's Betta Pharma, an oncology company. The funding was led by CICC Qide Innovative Biopharma Equity Investment Fund, CITIC Securities, Lyzz Capital and Huge Capital.

Cloudbreak Therapeutics, a US-China ophthalmology biopharma, completed a $25 million Series B round to support US Phase III trials of its lead product, CBT-001, a treatment for pterygium (see story). Pterygium is a common pinkish growth that starts in the corner of the eye and can spread to the cornea. An inflammatory condition, it can cause astigmatism or block the pupil. Cloudbreak also out-licensed greater China CBT-001 rights to China GrandPharma (HK: 0512) of Hong Kong for $10.5 million in upfront and milestone payments. In addition, Grand Pharma will invest $5.6 million to buy a 6.5% Cloudbreak stake.

Trials and Approvals

Beijing's BeiGene (Nasdaq: BGNE; HK: 06160) reported tislelizumab, its PD-1 antibody, was approved to treat urothelial cancer, the drug's second China-approved indication and first solid tumor indication (see story). In December 2019, tislelizumab was approved for classical Hodgkin's lymphoma. In urothelial cancer, tislelizumab is approved for locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed following chemotherapy. BeiGene says tislelizumab is currently being tested in 15 registration-enabling clinical trials, including 11 Phase III trials and four pivotal Phase II trials.

Harbour BioMed received China IND approval to conduct a seamless Phase II/III trial of HBM9161 in patients with adult immune thrombocytopenia (ITP). HBM9161, a fully human mAb targeting the neonatal Fc receptor (FcRn) (see story), accelerates the degradation of autoantibodies that drive ITP and other autoimmune disorders. HBM., which plans to begin clinical trials of HBM9161 in several other autoimmune diseases, in-licensed greater China rights to the candidate from Korea's HanAll Biopharma. HBM is headquartered in Boston with operations in Rotterdam and Shanghai.

Ascletis Pharma (HK: 1672) of Hangzhou reported its IND for a Phase IIb trial of its combination HIV candidate was approved in China (see story). Ascletis says ASC09 offers a much higher genetic barrier to resistance than other protease inhibitors, requiring seven mutations before resistance develops. ASC09F is a fixed-dose combination of a protease inhibitor (ASC09) and a generic drug, ritonavir. Ritonavir is a generic antiretroviral often used in HIV-combinations. Ascletis acquired greater China rights for ASC09 from Janssen Pharma in 2013.

Antengene, a Shanghai-US biopharma, has dosed the first patient in a Taiwan Phase I trial of ATG-019, a dual inhibitor of PAK4 and NAMPT (see story). The trial will enroll patients with advanced solid tumors or non-Hodgkin's lymphoma. Antengene says ATG-019 is a first-in-class, oral inhibitor targeting p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyl transferase (NAMPT). In 2018, Antengene in-licensed China rights to ATG-019 and three other novel oral cancer treatments from Karyopharm (NSDQ: KPTI) of Boston in an $162 million agreement.

Ansun Biopharma, a San Diego biopharma, enrolled the first patient in a US proof-of-concept study to evaluate the safety and efficacy of its treatment for severe COVID-19 infection (see story). DAS181 is a recombinant sialidase protein that cleaves sialic acid located on epithelial cells that line the respiratory tract, blocking virus entry. DAS181 is an inhaled therapy. In a recent China study of patients with severe COVID-19, DAS181 produced a significant improvement in all four patients. Ansun has raised $165 million from China investors including Sinopharm Healthcare Fund and Lilly Asia Ventures.

Hutchison China MediTech (Chi-Med) (Nasdaq/AIM: HCM) reported the US FDA has granted Fast Track Designations to surufatinib as a treatment for two pancreatic neuroendocrine tumor (NET) indications (see story). The indications are for advanced and progressive pancreatic NET and extra-pancreatic (non-pancreatic) NET in patients who are not amenable for surgery. In January, a China Phase III trial of surufatinib in NET was stopped early when data showed the candidate met its primary endpoint in an interim analysis. Surufatinib is an oral drug that inhibits angiogenesis and promotes a patient's immune response.

Coronavirus Pandemic

Sinovac Biotech (Nasdaq: SVA) of Shanghai has been approved to begin a China trial of its inactivated SARS-CoV-2 vaccine candidate (see story). The company says the vaccine has shown efficacy in animals and seems to be effective in virus strains from non-China countries. However, Sinovac also said China sales of its approved products have stopped because of the virus outbreak and exports have been slowed due to cancellations of cargo flights and inflated freight costs. It worries that continued disruption of the company's clinical trials, suppliers and contract manufacturers will slow development of new products.

Company News

Chime Biologics of Wuhan announced it has completed its separation from Taiwan's JHL Biotech, spinning out the CDMO operations into the new company (see story). In 2019, JHL settled an IP suit brought by Genentech by agreeing to stop development of four Genentech biosimilars. Chime's state-of-the-art 150,000 square feet facility, located in Wuhan BioLake, currently has five bioreactors with 9,000 L of total capacity. The company wants to become one of the largest CDMO providers in China by expanding capacity to 27,000 L by 2022 and 140,000+ L by 2024.