Cardiovascular diseases

B1140

Indication——AIS

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Product Introduction

B1140 is used for thrombolytic therapy of Acute Ischemic Stroke ,its mechanism of action is the same as that of PUK for treating STEMI.

Potential Advantages
 
(1) The new generation of fibrin-specific thrombolytic drug, with a unique mechanism of thrombolysis, low risk of systemic bleeding, and great safety;
(2) Low rate of re-thrombosis after thrombolysis;
(3) Advanced manufacturing process, and affordable to the patients; PUK has been covered in the National Reimbursed Drug List (NRDL) three times in a row.
Clinical Progress——Phase II
Given PUK has already been approved for treating STEMI, with the consent of NMPA, we directly started Phase II clinical trials of B1140.
B1140’s Phase II clinical trials were a randomized, open-label, multi-center, and controlled study to evaluate B1140’s safety and efficacy.
For the 0-4.5 hour treatment window study, patients were divided into two treatment groups receiving different doses of B1140 and one control group receiving rt-PA. For the 4.5-6 hour treatment window study, patients were divided into two treatment groups receiving different doses of B1140. We measured the efficacy of B1140 mainly through mRS (0-1) at 90 days and NIHSS.
The diagrams below illustrate the efficacy results of B1140’s Phase II clinical trials within both the 0-4.5 hour treatment window and the 4.5-6 hour treatment window:
Results from phase II clinical trials for B1140 (PUK 35 mg 和 50 mg ,rt-PA controlled 60mg):

Results of the 0-4.5 hour treatment window study show: in terms of both 90-day Modified Rankin Scale (mRS; 0-1) and 24-hour National Institute of Health Stroke Scale (NIHSS), the efficacy data of the two B1140 doses were comparable to those of recombinant tissue plasminogen activator (rt-PA); B1140 was found to have a lower rate of serious adverse drug reaction (SADR) and a lower rate of all-cause mortality than rt-PA, with a similar number of 90-day all-cause mortality to rt-PA. In terms of bleeding rate within 90 days after thrombosis, the 35mg dose was reported with a lower rate than rt-PA, and the 50mg dose was comparable to rt-PA.

Results of the 4.5-6 hour treatment window study show: both 90-day mRS (0-1) and 24-hour NIHSS for B1140 demonstrated enhanced efficacy and safety.

Notes: (1) The modified Rankin Scale(mRS) is a rating scale that assesses independent living ability. The modified Rankin Scale consists of seven scales, each with scale zero being no symptoms and scale six being death. A higher scale represents a worse prognosis of a patient. When evaluating the prognosis, lower than scale two is considered as positive prognosis. (2) The NIHSS is a commonly used measurement to objectively quantify the impairment of the body caused by a stroke. The NIHSS consists of 11 items. For each item, a score of zero typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient’s total NIHSS score.
 

Clinical Progress——Phase III

B1140 Phase III clinical trail is in progress