Previously, the "2021 Annual Drug Evaluation Report" released by the State Food and Drug Administration showed that in 2021, 53 (41 varieties) registration applications were included in the breakthrough therapeutic drug procedure
.
As of July 22, 27 drug varieties have been included in the breakthrough treatment list this year, including Repotrectinib capsules of Zaiding Pharmaceutical, SHC014748M capsules of Shenghe Pharmaceutical, BGB-3111 capsules of BeiGene, and TROP2 antibody conjugated drugs of
Kelun Botai.
It is worth noting that recently, with the help of a series of policies to encourage clinical value-oriented drug innovation and accelerate the listing of clinically urgently needed drugs with outstanding clinical value, a number of new drugs have been included in the list
of breakthrough treatment varieties.
STSP-0601 for injection was included in the list of breakthrough therapeutic varieties
STSP-0601 for injection was included in the list of breakthrough therapeutic varieties
On September 7, Shu Taishen announced that, according to the public information released by the Drug Evaluation Center (CDE) of the State Drug Administration, STSP-0601 for injection for bleeding in hemophilia A or B patients with inhibitors has been included in the list
of breakthrough treatment varieties.
According to the data, STSP-0601 (coagulation factor X activator) for injection is a national class I therapeutic biological product
.
It is understood that Shu Taishen was approved by the State Food and Drug Administration in May 2019 to accept the application for clinical trials of new drugs for injection STSP-0601, and the indication is hemophilia A or B patients with inhibitors for on-demand treatment
.
In July 2019, Shu Taishen received the "Clinical Trial Notice" issued by the State Food and Drug Administration on STSP-0601 for injection; In August 2021, a clinical study summary report on the phase I clinical trial of STSP-0601 for injection was obtained
.
In July 2022, the State Food and Drug Administration agreed to accept the clinical trial application
submitted by Shu Taishen and its wholly-owned subsidiary Beijing Novikang Pharmaceutical Technology Co.
, Ltd.
for the clinical trial of "bleeding on-demand treatment of hemophilia A or B patients without inhibitors" for the new indication of STSP-0601 for injection.
Kangfang Bio AK112 injection is proposed to be included in the breakthrough treatment varieties
Kangfang Bio AK112 injection is proposed to be included in the breakthrough treatment varieties
On August 31, according to the CDE announcement, an application for AK112 injection (Ivosi), one of the core products of KFANG Biologics, is intended to be included in the breakthrough treatment drug program, and the indications for development are: first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (TPS ≥ 1%)
.
AK112 is designed based on KF's unique TETRABODY technology, which blocks the binding of PD-1 to PD-L1 and PD-L2, and simultaneously blocks the bispecific antibody
of VEGF binding to VEGF receptors.
As a new generation of anti-tumor immunotherapy drugs, it has the potential for the development of "first-in-class", and if it is successfully included in the breakthrough treatment variety, it is expected to accelerate its development process
in China.
The industry expects that in the future, AK112 is expected to become another blockbuster double antibody drug with global breakthrough after the new drug of cardunilli (PD-1/CTLA-4 double antibody
).
Xinzhi Pharmaceutical BBM-H901 is proposed to be included in the breakthrough treatment
Xinzhi Pharmaceutical BBM-H901 is proposed to be included in the breakthrough treatment
On August 16, the CDE website showed that Shanghai Xinzhi Pharmaceutical Technology Co.
, Ltd.
"BBM-H901 Injection" is intended to be included in the breakthrough treatment variety to prevent bleeding in adult male patients with hemophilia B (congenital coagulation factor IX.
deficiency
).
It is understood that BBM-H901 injection belongs to class 1 therapeutic biological products, is a wholly-owned subsidiary of Faith Pharmaceutical, Xinzhi Pharmaceutical independently developed an AAV gene therapy drug, through intravenous administration of human coagulation factor IX (FIX) gene into the body of hemophilia B patients, thereby improving and long-term maintenance of the level
of coagulation factors in the patient's body.
BBM-H901 injection launched a researcher-initiated clinical study (IIT) in 2019 and was approved in August 2021, making it the first intravenous AAV gene therapy drug
for hemophilia approved to enter a registered clinical trial in China.
