publication date: Feb 5, 2022
author/source: Richard Daverman, PhD
Deals and Financings
Shanghai's HanBio Therapeutics raised $40 million in a Series A financing to advance its innovative biologic products (see story). HanBio is an early R&D company that was incubated by Sunshine Guojian Pharma. Its pipeline includes three bispecific antibodies in the IND and pre-IND stages, and a variety of early-stage antibodies and other biologics products. In 2022, HanBio plans to submit three INDs in China and the US for innovative bispecific antibody products. This round of financing was jointly led by OrbiMed and Hankang Capital. It also included Yonghua Investment and Elikon Investment.
Australia's Beroni Group (OTCQX: BNIGF; NSX: BTG) announced plans to build an R&D center in China's Zhuhai National High-Tech Industrial Development Zone (see story). Beroni's drug development pipeline focuses on oncology and immunotherapy. The company will build a state-of-the-art facility with new preclinical research labs, manufacturing process development labs, and a GMP pilot manufacturing plant. The facility will help Beroni bring new drugs to China. The company's Penao is a novel oncology therapy currently in Phase II trials that targets tumor cell mitochondria. Beroni has allocated $10 million for new clinical trials at the facility.
Trials and Approvals
Sweden's Xvivo Perfusion AB announced its ready-to-use lung perfusion product, Perfadex Plus, was approved for China use with lung transplants (see story). Perfadex Plus facilitates flushing, cold static storage and transportation of donated lungs. Xvivo says Perfadex Plus, and the original product, Perfadex, are used by more than 90% of all lung transplant clinics in the world. A lung transplant is the last resort for patients with end-stage lung disease. China is now the second largest transplant market in the world.
Hangzhou's Akeso (HK: 9926) has dosed the first patient in a Phase III trial of its bi-specific novel immuno-oncology drug, ivonescimab (see story). It is being tested in non-squamous non-small cell lung cancer patients with an EGFR mutation who had failed an EGFR-TKI treatment. Ivonescimab, a PD-1/VEGF bi-specific antibody, will be administered along with chemotherapy. Akeso said an immunotherapy/anti-angiogenesis combination is a promising therapy because the anti-angiogenic arm normalizes tumor blood vessels, improving the tumor microenvironment for the immunotherapy.
Shanghai Hutchmed (NSDQ/AIM: HCM; HK: 13) started a China Phase Ib/II study of its novel FGFR 1/2/3 inhibitor combined with chemotherapy or toripalimab, an anti-PD-1 therapy (see story). The two-stage, open-label clinical trial will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-453 in patients with advanced or metastatic solid tumors. Hutchmed is also testing HMPL-453 as a monotherapy in patients with advanced intrahepatic cholangiocarcinoma . Toripalimab, a Shanghai Junshi Bio (HK: 1877; SHA: 688180) product, is the first China-developed PD-1 approved for use in China.
Suzhou Kintor Pharma (HK: 9939) dosed the first patient in a US Phase I clinical trial of its therapy for androgenetic alopecia and acne (see story). Kintor says GT20029 (gel) is the first topical Proteolysis Targeting Chimera compound globally to start trials. It began a China clinical study six months ago. The candidate blocks the androgen receptor pathway by degrading the AR protein. Kintor is developing a pipeline of novel small molecule and biological therapeutics for androgen-receptor-related diseases including COVID-19, prostate, breast and liver cancer, alopecia and acne.
Shanghai Dizal Pharma (SHA: 688192) was granted Breakthrough Therapy Designation in the US for sunvozertinib as a second-line therapy in non-small cell lung cancer patients (see story). The specific indication is patients with locally advanced or metastatic NSCLC and epidermal growth factor receptor (EGFR) exon20 insertion mutations. The patients must have disease that progressed following platinum-based chemotherapy. Sunvozertinib, which also has Breakthrough status in China, is currently in pivotal Phase II trials in China and the US. In 2017, Dizal was formed as an AstraZeneca JV with AstraZeneca assets after the company closed its Shanghai R&D Center.