Deals and Financings

Shanghai CARsgen Therapeutics is staging an IPO on the Hong Kong Exchange that could raise $400 million to support development of the company's CAR-T portfolio (see story). The shares are scheduled to begin trading on June 18. Lilly Asia Ventures and New China Life are among nine cornerstone investors that will acquire $230 million of the shares. CARsgen is advancing 11 candidates for solid tumors and hematological malignancies including six clinical stage molecules. The company's lead drug is a BCMA CAR-T for multiple myeloma currently in a pivotal Phase II/III trial.  

Dingdang Health, a Beijing online healthcare company, raised $220 million in its latest financing round, led by TPG Capital Asia and co-led by OrbiMed and Redview Capital (see story). Dingdang offers online-to-offline medicine delivery that provides drug delivery in less than 28 minutes in urban core areas or via existing stores elsewhere. In addition to retail pharmaceuticals, it offers online medical consultations, chronic disease management and psychological consultations. Other investors in the round included Valliance, Travis Global Limited, Summer Capital, and Yingke PE.  

Shanghai Nuance Pharma acquired greater China rights to a novel COPD treatment from Verona Pharma of London in a $219 million deal (see story). Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4, offering both bronchodilator and anti-inflammatory effects. Verona is currently testing ensifentrine in a global Phase III trial as a maintenance treatment for chronic obstructive pulmonary disease. Nuance will make a $25 million upfront payment and a $15 million investment in Verona, plus milestones of up to $179 million and royalties.  

Ambrx, a San Diego clinical-stage biotech with operations in Shanghai, filed for a US IPO that is expected to raise $100 million (see story). Founded in 2003, Ambrx develops antibody-drug conjugates and bispecifics for unmet oncology needs. It builds engineered precision biologics by incorporating synthetic amino acids (SAAs) into proteins within living cells, a technology that offers better efficacy and safety, according to the company. Its lead drug, an ADC candidate, is being tested in a China Phase II/III trial for HER2-positive metastatic breast cancer led by a China partner, NovoCodex Biopharma.  

Trials and Approvals 

Beijing's BeiGene (NSDQ: BGNE; HK: 06160) presented positive interim results from Phase III trial that compared its BTK candidate to AbbVie's Imbruvica (ibrutinib) (see story). In the trial, BeiGene's Brukinsa® (zanubrutinib) produced a 78.3% overall response rate compared to imbrutinib's 62.5%. The trial was conducted in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The progression free survival rate at 12 months was 94.9% in the Brukinsa arm, compared to 84.0% in the ibrutinib arm. 

Suzhou Innovent Bio (HK: 01801) and HutchMed (NSDQ/AIM: HCM) announced their combination therapy successfully completed an early trial in colorectal cancer patients (see story). The regimen combines Innovent's approved PD-1, Tyvyt® (sintilimab injection) with HutchMed's VEGFR inhibitor, Elunate® (fruquintinib), as a third-line therapy for CRC. In 44 previously treated CRC patients, the objective response rate was 22.7%, about double the ORR of Elunate alone. The Phase Ib trial tested safety and efficacy of the combination and determined the recommended Phase II dose.  

CBMG Holdings, a US-China immunotherapy company, said its novel bi-specific CAR-T candidate was effective in an early-stage China lymphoma trial (see story). C-CAR039, a second-gen 4-1BB CD19/CD20 bi-specific, produced an overall 92% overall response rate in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The complete response rate was 85%. In addition, the US FDA granted orphan drug designation to C-CAR039 in patients with follicular lymphoma. CBMG was known as Cellular Biomedicine before it was taken private in a management-led buyout.  

Ascentage Pharma (HK: 6855), a Suzhou company, reported its Bcl-2 inhibitor successfully completed an early trial in hematologic malignancies (see story). Lisaftoclax (APG-2575) showed an objective response rate of 80% in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and other hematologic malignancies. Previously, patients had received a median of two treatments for their disease. The results were reported in an oral presentation at the 57th ASCO Annual Meeting, one of four Ascentage presentations at the meeting.  

Innovent Bio (HK: 01801) of Suzhou and Nanjing IASO Bio posted positive data from a Phase I trial of their CAR-T therapy in multiple myeloma patients (see story). CT103A, a BCMA CAR-T candidate, produced a 97% overall response rate (ORR) in 35 patients with relapsed/refractory multiple myeloma. Of these, 20 patients (57%) experienced a complete response. The two companies have already started a pivotal China Phase II trial in the same population. In February 2021, CT103A was granted Breakthrough Therapy Designation in China.  

Shanghai OriginCell Therapeutics presented encouraging data from an on-going trial of its GPC3 CAR-T cell therapy in patients with relapsed/refractory hepatocellular carcinoma (HCC) (see story). Ori-CAR-001 produced a 44.4% objective response rate and a 77.8% disease control rate in the eleven enrolled patients, all of whom had received two previous treatments. OriginCell has built four technology platforms, including an antibody development platform, a high-memory CAR T technology platform, a cell expansion platform and a universal CAR-T platform. OriginCell is aiming Ori-CAR-001 at solid tumor cancers.  

Hangzhou's Ascletis Pharma (HK: 1672) was approved to conduct trials of ASC42 in patients with chronic hepatitis B (CHB) (see story). ASC42 is a novel oral farnesoid X receptor (FXR) agonist that Ascletis developed in-house. In two pre-clinical tests, ASC42 significantly inhibited serum hepatitis B surface antigen (HBsAg) and HBV pregenomic RNA (pgRNA). Ascletis believes the candidate has potential to cure CHB. Previously, ASC42 was approved in China to treat NASH.  

Disclosure: none.