AnHeart Announces Publication of Pooled Analysis of two Phase 1 Studies of Taletrectinib in ROS1+ NSCLC

Progression-Free Survival of 29.1 months reported in ROS1 TKI treatment-naïve patients and 14.1 months in patients pre-treated with one prior ROS1 TKI

Hangzhou, China/New York October 29, 2020AnHeart Therapeutics, Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, announces publication of a pooled analysis of two Phase 1 trials of its lead compound, taletrectinib, a next-generation ROS1/NTRK inhibitor in JTO Clinical and Research Reports[1], an official journal of the International Association for the Study of Lung Cancer.

In the publication, 22 ROS1+ NSCLC patients out of the total 61 patients enrolled into the two Phase 1 studies conducted in the U.S. (U101, NCT02279433) and Japan (J102, NCT02675491) were analyzed for objective response rate (ORR) by RECIST 1.1, progression-free survival (PFS) and safety. Data cutoff was August 19, 2020. Median follow up time for all 22 patients was 14.9 months.

18 of the 22 ROS1+ patients were evaluable for response. The confirmed ORR for ROS1 tyrosine kinase inhibitor (TKI) treatment-naïve patients (N = 9) was 66.7% with a disease control rate (DCR) of 100%. The confirmed ORR for patients pre-treated with one prior ROS1 TKI (N = 6) was 33.3% and DCR of 88.3%. The confirmed ORR for patients pre-treated with two prior ROS1 TKI (N = 3), the ORR was 33.3% (95% CI: 6.1% – 79.2%) with a DCR of 66.7%. The median PFS was 29.1 months for ROS1 TKI treatment-naïve patients (N= 11), 14.2 months for patients pre-treated with one prior ROS1 TKI (N = 8), and 4.1 months for patients pre-treated with two prior ROS1 TKIs (N=3).

Dr. Sai-Hong Ignatius Ou, MD PhD, the lead and corresponding author of this publication from the Chao Family Comprehensive Cancer Center, Department of Medicine, Division of Hematology-Oncology, University of California Irvine School of Medicine, said: “In the two Phase 1 studies, taletrectinib demonstrated meaningful clinical activity in advanced ROS1+ NSCLC patients who are ROS1 TKI-naïve or crizotinib-refractory and had a manageable safety profile.”

“We continue to gain additional confidence in taletrectinib, which has strong potential to be the best-in-class selective ROS1/NTRK inhibitor,” commented Bing Yan, MD, Chief Medical Officer of AnHeart. “Our Phase 2 trial of this compound is actively enrolling patients in China, and we expect to announce early interim data in Q3 2021. AnHeart also plans to start the ex-China Phase 2 taletrectinib trial in early 2021 to pursue global registration for indications of NSCLC with ROS1 fusions and solid tumors with NTRK fusions.”

About AnHeart:

AnHeart Therapeutics Co., Ltd. (“AnHeart”) is a clinical stage biopharmaceutical company developing novel oncology therapies. AnHeart is headquartered in Hangzhou, China with offices in Beijing, Shanghai and has a subsidiary AnHeart Therapeutics Inc. in New York. Formed in November 2018, AnHeart is currently managed by biopharmaceuticals industry veterans and financially backed by venture capital funds.

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AnHeart Contact:

Akira Jing Liu, MD

Director of Business Development

(86) 137-0181-9470 (c)

ajliu@anhearttherapeutics.com

Investor Relations Contact:

Irina Koffler

Managing Director

LifeSci Advisors, LLC

646-970-4681 (w)

917-734-7387 (c)

ikoffler@lifesciadvisors.com

[1] See https://www.sciencedirect.com/science/article/pii/S2666364320301545

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