Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina

Dantonic® (T89) is a botanical drug consists of extracts of Danshen (Radix Salviae
Miltiorrhizae) and Sanqi (Radix Notoginseng) with borneol in a capsule form. The drug is
currently approved in 26 countries outside the USA for the treatment and prevention of
chronic stable angina pectoris and other cardiovascular disease related conditions. This
pivotal confirmative Phase III clinical trial is to confirm the efficacy and safety of the
drug at 150mg and 225mg doses in the prevention and treatment of angina pectoris in patients
with Chronic Stable Angina. The contribution of the main herb Danshen to, and the difference
of various production batches in, the overall efficacy and safety profiles will also be
explored. Patients will take a morning and an evening dose orally (every 12 hours) for 6
weeks while stop taking any long-acting nitroglycerin, ranolazine, and/or multiple
beta-blockers or beta blocker(s) with calcium channel blocker during the trial. Single
beta-blocker and/or on-demand short acting nitroglycerin to relief angina pectoris is
allowed during the trial. After physical exams and if eligible to participation, patients
will stop taking other drugs, and undergo two baseline screen Exercise Treadmill Tests (ETT)
on Standard Bruce Protocol in the clinic one week before and right before starting the drug
treatment. Patients will perform three more ETTs before the morning dose at the end of week
2, 4 and 6 after receiving the drug treatment. The primary efficiency endpoint is the change
of symptom-limited Total Exercise Duration of the ETT at the end of the 4th week of
treatment from the average of the two screening baselines compared with that of placebo
treatment.

Inclusion Criteria:

1. Written informed consent.

2. Males and females between the ages of 20 and 80 years.

3. Females of childbearing potential must have a negative pregnancy test, not be breast
feeding and established on a method of contraception that in the investigator's
opinion is acceptable. Females must agree to remain on their established method of
contraception through their participation in the study and for 14 days following the
last dose of study drug.

4. Evidence of coronary artery disease that consists of a well-documented medical
history (over 3 months prior to the enrolment) of myocardial infarction or
significant coronary artery disease with noninvasive or angiographic confirmation.

5. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal
exercise response limited by angina and/or electrocardiograph (ECG) changes.

6. Moderate angina pectoris (Class II or III, Grading of Angina Pectoris by the Canadian
Cardiovascular Society Classification System).

7. Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutes
in Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TED
on two screen examinations (Day -7 and 0) in which the shorter is within 85% of the
longer .

8. Patient has been on one beta-blocker or on one calcium-channel blocker for at least
14 days prior to dosing of study medication and can remain on this treatment
throughout the study as background anti-anginal treatment. Short-acting nitroglycerin
for on-demand use is allowed for all eligible patients.

9. Understand and be willing, able and likely to comply with all study procedures and
restrictions and comprehends the verbal rating scales and diary cards.

Exclusion Criteria:

1. With contraindication to, unable to, or with other co-morbidities that may prevent or
interfere with the ability to perform treadmill ETT (including, but not limited to:
pulmonary hypertension, functionally limiting COPD (chronic obstructive pulmonary
disease), history of pulmonary tuberculosis, prior hospitalization for acute
exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy
that can limit exercise capacity, functionally limiting peripheral artery disease,
etc.).

2. Presence of electrocardiographic or other abnormalities/factors that could interfere
with exercise electrocardiograph interpretation or may lead to a false positive
stress test (e.g., pre-exercise horizontal or down-sloping ST segment depression in
any standard lead, cardiac glycoside therapy, Lown-Ganong-Levine Syndrome,
Wolff-Parkinson-White syndrome (WPW), left bundle branch block, left ventricular
hypertrophy with repolarization abnormality, implanted pacemaker, etc.).

3. Clinically significant arrhythmias or atrioventricular conduction block greater than
first degree, decompensated heart failure, atrial fibrillation, hypertrophic
cardiomyopathy.

4. Acute coronary syndrome (acute myocardial infarction or unstable angina) in the prior
2 months or coronary revascularization within the prior 6 months or planned coronary
revascularization during the study period.

5. Congenital cardiac defects, ongoing history of decompensated congestive heart
failure, severe valvular disease, severe uncontrolled hypertension (seated systolic
blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), severe anemia,
suspected or known dissecting aortic aneurysm, acute myocarditis or pericarditis,
thrombophlebitis or pulmonary embolism.

6. History of bleeding diathesis, cerebral hemorrhage, or seizure disorders that
required anticonvulsant medication.

7. Patients requiring the use of long-acting nitroglycerin, ranolazine, and/or multiple
anti-anginal drugs.

8. Aspirin and/or statins started less than 14 days prior to the signing of informed
consent.

9. Pregnancy or lactation.

10. Clinical trials/experimental medication 1) Participation in any other clinical trial
or receipt of an investigational drug within 30 days prior to the initial visit.

2) Previous participation in the studies of T89. 11. Substance abuse. Patients with a
recent history (within the last 2 years) of alcoholism or known drug dependence.

12. Is a family member or relative of the study site staff. 13. Any other conditions that,
in the opinion of the investigator, are likely to prevent compliance with the study
protocol or pose a safety concern if the subject participates in the study.