publication date: Sep 25, 2021
author/source: Richard Daverman, PhD
Deals and Financings
Broncus Holding (HK: 2216), a Hangzhou pulmonary medical device company, completed a $200 million IPO on the Hong Kong exchange that valued the company at nearly $1.3 billion (see story). Its products, which are marketed in China and globally, address navigation, diagnosis and treatment needs for lung cancer, COPD and emphysema. The IPO was priced at the top end of the range, but on its first day of trading, Broncus' shares dropped 20%. Founded in 2012, Broncus posted net losses of $32.6 million in 2019 and $48.8 million in 2020, with revenue falling 59% in 2020.
Impact Therapeutics of Nanjing will collaborate with Toronto's Cyclia. using Cyclia's Ligand Express data-based platform to assess the "targetivity" of their novel oncology candidates (see story). Impact said the insights gained from the partnership will improve and validate its assets, which are based on synthetic lethality. The company has developed a portfolio of DNA damage response candidates using its in-house discovery work and is expanding to other novel targets. Impact's lead drug is a clinical stage PARP inhibitor that it has partnered with Shanghai's Junshi Biopharma (HK: 1877; SHA: 688180).
Clover, a Chengdu vaccine/biologic company, reported its adjuvanted protein-based COVID-19 vaccine candidate met its endpoints in a global, 30,000 person pivotal Phase II/II trial (see story). SCB-2019 (CpG 1018/Alum) prevented 100% of severe COVID-19 vaccine and hospitalizations in all SARS-CoV-2 strains. Overall efficacy was 67% against COVID-19 of any severity caused by any strain. It posted 79% overall efficacy against COVID-19 of any severity in Delta subjects. Clover's trial was supported by CEPI, the Coalition for Epidemic Preparedness Innovations.
Trials and Approvals
Akeso (HK: 9926) reported an NDA for its self-developed PD-1/CTLA-4 bi-specific antibody has been accepted for review in China under priority status (see story). The company said cadonilimab is the first bi-specific antibody drug in the world to submit an NDA. In a pivotal Phase II trial, Akeso tested cadonilimab as a second line therapy in patients with relapsed or metastatic cervical cancer. One month ago, Akeso and its partner, Sino Bio (HK: 1177) were approved to launch their partnered anti-PD-1 injection in China for classic Hodgkin's lymphoma.
Suzhou CStone Pharma (HK: 2616) and US-based EQRx reported their partnered PD-(L)1 antibody increased median progression-free survival from 5.8 months to 9.0 months in Stage III NSCLC patients (see story). The data was from a China Phase III trial among previously treated NSCLC patients. In late 2020, CStone out-licensed ex-China rights for its PD-(L)1 and PD-1 candidates to EQRx in a $1.3 billion deal ($150 million upfront). CStone sold China commercialization rights for the candidate to Pfizer in a $480 million agreement.
Shanghai Hutchmed (NSDQ/AIM: HCM; HK: 13) announced it is starting a Phase III combination trial of its surufatinib and Junshi's PD-1 in patients with advanced neuroendocrine carcinoma (NEC) (see story). Hutchmed's Sulanda® (surufatinib), an anti-angiogenesis EFGR kinase inhibitor, and Junshi's Tuoyi® (toripalimab) immunotherapy are both approved in China. In a Phase II trial, the combination produced an objective response rate of 20% and disease control rate of 70%. Median progression-free survival was 3.9 months.
HighTide Therapeutics, a Shenzhen-Maryland biopharma, published positive data from a US Phase II trial of its novel treatment for NASH and type 2 diabetes (see story). HTD1801, a novel oral ionic salt of berberine and ursodeoxycholic acid combination, reduced liver fat while improving glycemic control and other cardiometabolic biomarkers. Patients were assessed after 18 weeks of treatment. The results were published online in Nature Communications. In May 2020, HighTide reported similar results from a China trial of HTD1801.
CARsgen Therapeutics (HK: 2171) of Shanghai reported positive data from a China investigator-initiated trial of its Claudin18.2 CAR-T therapy in patients with digestive system tumors (see story). In 36 patients who had previously been heavily pre-treated, CT041 produced an overall response rate of 48.6% and a disease control rate of 73.0%. This compares to a historical efficacy rate of 4% to 8% from chemotherapy and 11% for an anti-PD-1 antibody. CT041 is the only Claudin18.2 CAR-T in China and US clinical trials.
Beijing InnoCare (HK: 09969) and Chengdu's Keymed (HK: 02162) announced their IND for a CD20xCD3 bispecific antibody was cleared in China (see story). CM355 binds to CD20 on tumor cells and CD3 on T cells using T-cell Directed Cellular Cytotoxicity (TDCC) to treat CD20+ B-cell malignancies. Non-Hodgkin lymphomas make up 80%-90% of all CD20+ B-cell malignancies. A joint venture formed by the two companies, Tiannuojiancheng Pharma, developed the bispecific.