Biopharma Innovation in China Showcased at CSCO 2021

Authored by Clarion, now part of Lumanity

China’s pharmaceutical market has been growing rapidly and is now the second-largest in the world after the United States.^1,2 China has also invested heavily in growing its R&D capabilities¹, and its domestic biopharma pipeline has grown to well over 800 products in oncology, including hundreds of first-in-class compounds.^3,4,5

The Clarion team participated in the virtual 2021 Chinese Society of Clinical Oncology (CSCO) Annual Meeting in September, and found clear evidence of China’s emergence as a biopharma innovator. The following are just a few examples of the data presented:

First-in-class bispecific antibody (BsAb) therapies targeting immune checkpoints

• Anti-PD-1/VEGF BsAb, AK112 [Akeso]: This year’s CSCO saw the first data readout of AK112’s ongoing phase 2 trial in front-line treatment of non-small cell lung cancer (NSCLC). Although early, the efficacy was promising: ORR of ~54% overall (n=26) and ~64% in PD-L1-positive patients (n=11)⁶
• Anti-PD-1/HER2 BsAb, IBI315 [Hanmi and Innovent Biologics]: CSCO also saw the first data from the first-in-human phase 1 trial of IBI315, demonstrating favorable safety (MTD not reached) and a preliminary ORR of 20% in pretreated, HER2-expressing solid tumors at dose levels ≥1 mg/kg (n=15; range tested was 0.03 to 15 mg/kg)⁷

Other first-in-class immunotherapies

• IL-7 fusion protein, TJ107 (a.k.a. Hyleukin-7, NT-I7) [I-Mab, Genexine, NeoImmuneTech]: The first clinical data for this unique, long-acting cytokine product (IL-7-HyFc dimer) was presented at CSCO: safety and PK/PD were favorable, though efficacy results are still pending⁸
• Anti-PD-1 nanobody-secreting, anti-mesothelin CAR-T cell therapy [Shanghai Cell Therapy Group]: CSCO saw the first preliminary data readout of the phase 1 trial, showing 1 complete response out of 5 previously treated, malignant mesothelioma patients⁹

First clinical data reports for novel antibody-drug conjugate (ADC) products

• Anti-Trop2 ADC SKB264 [Sichuan Kelun Pharma] strives to differentiate from other Trop2-targeted ADCs with a distinct payload (belotecan-derived) and novel linker chemistry. Early data reported at CSCO for relapsed/refractory solid tumors included partial responses in gastric cancer, HER2-positive breast cancer, and triple-negative breast cancer patients¹⁰
• Anti-HER2 ADCs MRG002 [Shanghai Miracogen] and ARX788 [Ambrx] both use microtubule-disrupting payloads—MMAE and amberstatin269, respectively—that are distinct from the payloads used by approved ADCs Kadcyla (maytansine, or DM1) and Enhertu (exatecan derivative DXd). In new data presentations at CSCO, both novel ADCs showed ~50% ORR in HER2-positive solid tumors in their respective ph1/2 trials^11,12

In addition to showcasing China’s growth in biopharma innovation, our attendance of CSCO also reveals this conference as one to monitor closely moving forward, as a forum where new data for new cancer therapies will increasingly be reported for the first time.