Baoyuan Pharmaceutical and Cinda Biotech announce the interim data of the phase II trial of taletrectinib for ROS1-positive non-small cell lung cancer at the CSCO 2021 meeting

Among 21 patients who were not treated with crizotinib, the confirmed objective response rate (ORR) was 90.
5% (19/21), and the disease control rate (DCR) was 90.
5% (19/21)
.

Among the 16 patients who had been treated with crizotinib, the confirmed objective response rate (ORR) was 43.
8% (7/16), and the disease control rate (DCR) was 75.
0% (12/16)
.

Hangzhou, China/New York, September 27, 2021-Baoyuan Biomedical Technology (Hangzhou) Co.
, Ltd.
(hereinafter referred to as "Baoyuan Pharmaceutical"), a clinical stage dedicated to the development of a new type of first-in-class or best-in-class precision tumor therapy The company, together with Cinda Bio-Pharmaceutical Group (Hong Kong Stock Exchange stock code: 01801) (hereinafter referred to as "Cinda Bio"), a company dedicated to R&D, production and sales of innovations for the treatment of tumors, metabolic diseases, autoimmunity and other major diseases The drug's biopharmaceutical company jointly announced the interim data of the Phase II trial of the new generation of ROS1/NTRK inhibitor taletrectinib under development for ROS1-positive non-small cell lung cancer
.

The data will be announced in the form of a conference theme report at the 2021 Chinese Society of Clinical Oncology (CSCO) annual meeting held on September 25-29
.

The title of the conference theme report is "taletrectinib (AB-106): A new generation of potent ROS1/NTRK inhibitors in the treatment of ROS1-positive non-small cell lung cancer Phase II study (TRUST study) preliminary study results"
.

The report summarized preliminary data from the phase II trial of taletrectinib (NCT04395677)
.

As of June 16, 2021, a total of 21 patients who have not received crizotinib treatment and 16 patients who have received crizotinib treatment have been confirmed to be ROS1 positive.
The main results are as follows: · In those who have not received crizotinib treatment Among 21 patients, the confirmed objective response rate (ORR) was 90.
5% (19/21), and the disease control rate (DCR) was 90.
5% (19/21)
.

· Among the 16 patients who had received crizotinib, the confirmed objective response rate (ORR) was 43.
8% (7/16), and the disease control rate (DCR) was 75.
0% (12/16)
.

· Among the 16 patients who had received crizotinib treatment, 3 patients were confirmed to be positive for the ROS1 G2032R resistance mutation.
All 3 patients showed tumor shrinkage, and two of them achieved partial remission (PR), 1 Patients are in stable disease (SD) state
.

· Among patients with evaluable brain metastases before enrollment, the objective response rate in the brain assessed by the investigator was 83.
3% (5/6)
.

· Taletrectinib is well tolerated, and treatment-related adverse events mainly include gastrointestinal adverse events and reversible AST and ALT elevations
.

"We are pleased to see that the interim data of Phase II initially indicates that taletrectinib is safe and tolerable, and it is very promising to become a new type of therapy for ROS1 fusion-positive lung cancer
.

" said Professor Zhou Caicun, director of the oncology department of Shanghai Pulmonary Hospital.
"Taletrectinib has shown satisfactory efficacy in patients who have not been treated with crizotinib.
In patients treated with crizotinib, although the number of patients is limited, most patients continue to benefit from treatment.

.

"Our team is highly focused on the enrollment of the TRUST trial," said Dr.
Yan Bing, co-founder and chief medical officer of Baoyuan Pharmaceutical.
"The interim data presented by the TRUST trial establishes a solid foundation for our ongoing global key trials.
Foundation
.

We sincerely thank the patients and their families and researchers who participated in the TRUST trial.
This is an area with significant unmet medical needs.
We look forward to advancing the clinical development of taletrectinib for all ROS1 fusion-positive NSCLC patients.
Some patients bring new treatment options
.

"We are very pleased to see that the interim data of the phase II trial of taletrectinib can be published at the CSCO conference, one of the most authoritative clinical oncology conferences in China," said Dr.
Zhou Hui, senior vice president of Cinda Biotech.
"Currently, ROS1 is positive in China.
Patients have limited treatment options, and more new drugs are urgently needed
.

Taletrectinib has shown good results in terms of effectiveness and safety, which brings hope to patients with ROS1 fusion-positive non-small cell lung cancer
.

"About taletrectinib Taletrectinib is a new generation of tyrosine kinase inhibitors (TKI) under development.
It targets ROS1 and NTRK fusion mutations and has the potential to treat patients who have not been treated with TKI and who have undergone TKI treatment
.
The
ROS1 fusion mutation is about 2 %~3% of patients with advanced NSCLC are carcinogenic drivers.
NTRK fusion mutations are the carcinogenic drivers of about 0.
5% of other patients with advanced solid tumors
.

You can search for clinical trial numbers NCT04395677 and NCT04617054 at https://clinicaltrials.
gov to find More information about the ongoing TRUST trial and the NTRK fusion-positive solid tumor basket trial
.

About Baoyuan Pharmaceutical Baoyuan Biomedical Technology (Hangzhou) Co.
, Ltd.
(hereinafter referred to as Baoyuan Pharmaceutical") is a clinical-stage biomedical company focusing on the development of new types of first-in-class or best-in-class precision tumor therapies
.

Baoyuan Pharmaceutical’s main asset, taletrectinib, is the next-generation ROS1/NTRK inhibitor, currently in phase II, for the first-line and second-line treatment of non-small cell lung cancer
.

Baoyuan Medicine is building a rich product line for a new generation of precision treatments for urgently needed and unmet medical needs
.

For details, please visit the company website: https://anhearttherapeutics.
com/
.

About Cinda Bio, "Starting from Faith and Reaching from Action", it is Cinda Bio's ideal and goal to develop high-quality biological drugs that the people can afford
.

Founded in 2011, Cinda Bio is committed to the development, production and sales of innovative drugs for the treatment of tumors, autoimmune, metabolic diseases and other major diseases
.

On October 31, 2018, Cinda Biopharmaceuticals was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801
.

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.

A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.
Among them, 6 varieties have been selected for the national "Major New Drug Creation" project
.

The company has 5 products (sintilimab injection, trade name: Daboshu®, English trademark: TYVYT®; bevacizumab biosimilar drug, trade name: Dayotong®, English trademark: BYVASDA ®; Adalimumab biosimilar drug, trade name: Su Lixin®, English trademark: SULINNO®; Rituximab biosimilar drug, trade name: Dabohua®, English trademark: HALPRYZA®; pemigatinib oral inhibitor , Trade name: dalbotan®, English trademark: PEMAZYRE®) was approved for marketing by NMPA, 1 product marketing application was accepted by NMPA, Sintilimab's application for marketing in the United States was accepted by FDA, and 5 varieties entered phase III or Critical clinical research, and another 15 products have entered clinical research
.

Cinda Bio has established an internationally advanced high-end biopharmaceutical development and industrialization talent team, including many returned experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi of South Korea.
Reach strategic cooperation
.

Cinda Bio hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to medicines and the people's pursuit of life and health
.

For details, please visit the company's website: or the company's LinkedIn account
.

Contact: Baoyuan Pharmaceutical Media: Kimberly HaKKH Advisorskimberly.
ha@kkhadvisors.
com+1 917-291-5744 Baoyuan Pharmaceutical Investor: ir@anhearttherapeutics.
com+1 212-466-6378 Xinda Biomedia: Email: pr @innoventbio.
com Tel: +86 512-69566088 Innovent Bio Investor: Email: ir@innoventbio.
com Tel: +86 512-69566088