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On October 25, 2022, Primal Biotechnology (Shanghai) Co.
, Ltd.
(hereinafter referred to as "Primeval Biotechnology") announced that it has received an official written reply from the Office of Orphan Products Development (OOPD) of the US Food and Drug Administration (FDA).
Its original GPRC5D-targeted chimeric antigen receptor T cell product, OriCAR-017, was granted orphan drug designation (ODD) for the treatment of relapsed/refractory multiple myeloma (R/R MM).
This orphan drug designation is mainly based on the positive results of the first-in-human (FIH) phase I clinical study of OriCAR-017 product in China (NCT05016778).
After obtaining orphan drug designation, OriCAR-017 products will be eligible for several preferential policies, including FDA guidance support for clinical studies, special fee waivers, and seven-year market exclusivity in the United States after approval of the market
.
Yang Huanfeng, chairman of Yuanqi Biotechnology, said:
Yang Huanfeng, chairman of Yuanqi Biotechnology, said: "I am very proud of our team, following the approval of OriC-101 by the NMPA to start registration clinical trials one month ago, OriCAR-017 has been designated as an orphan drug by the FDA, which not only proves the recognition of our products by the NMPA, FDA review departments and the industry, but also marks that OriC-017 has entered the clinical development stage
from new drug research and development.
The FDA orphan drug designation is an important milestone in the development process of OriCAR-017 products, which has played a positive role
in accelerating the clinical development of OriCAR-017 in China and the United States and its future registration.
Primeval is committed to becoming the world's leading creator of
new drugs for tumor immunotherapy.
We are accelerating the pace of progress and are confident that through unremitting exploration and efforts, we can provide more effective and diversified treatment methods
for patients around the world at an early date.
”
About OriCAR-017
About OriCAR-017 OriCAR-017 is one of the core products developed by Primeval based on two independent research and development technology platforms of OriAb and OriCAR, and autologous GPRC5D-targeted chimeric antigen receptor T cell therapy is used for the treatment of relapsed/refractory multiple myeloma (R/R MM).
。 On April 30, 2022, the investigators conducted a clinical phase I POLARIS clinical trial in China to demonstrate good safety and efficacy (100% ORR, 28-day MRD 10-5 negative rate 100%), all subjects, including those who had failed previous BCMA CAR-T treatment, achieved sustained remission without progression at the data cut-off date without any additional anti-tumor treatment
.
The findings were presented
orally at the 2022 ASCO and 2022 EHA Annual Meetings.
On October 24, 2022, it was designated
as an "orphan drug" by the Office of Orphan Drug Product Development (OOPD) of the US FDA for GPRC5D (OriCAR-017).
(See for
more information.
)
About FDA Orphan Drug Designation (ODD)
About FDA Orphan Drug Designation (ODD) "Orphan drugs", also known as rare disease drugs, refer to drugs used to prevent, treat, and diagnose rare diseases, and the FDA has clear definition criteria for rare diseases, that is, diseases
that affect less than 200,000 people in the United States.
Orphan Drug Designation is a qualification granted by the FDA's Office of Orphan Drug Product Development (OOPD) to eligible drugs (including biological products) for the prevention, treatment and diagnosis of rare diseases
.
Orphan drug qualification plays a pivotal role
in the research and development of new drugs.
Drugs that obtain ODD can enjoy corresponding benefits in policy, including a series of incentive policies
such as 7 years of marketing exclusivity after new drugs are approved for marketing, exemption from NDA/BLA application fees, tax deductions for clinical research fees, and possible exemption from reporting requirements for some clinical data 。 (See for
more information.
)
About Multiple Myeloma (MM)
About Multiple Myeloma (MM) Multiple myeloma (MM), one of the most common blood cancers, is a malignant disease
in which clonal plasma cells proliferate abnormally.
For treatment-naïve patients with multiple myeloma, commonly used first-line therapies include proteasome inhibitors, immunomodulatory drugs, and alkylating agents
.
For most patients, commonly used first-line treatment can stabilize the patient's condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled
.
For most treatment-naïve patients who respond to treatment, they will inevitably enter the relapse and refractory stage
after the stable period of the disease.
As a result, there is still an unmet need
in patients with relapsed/refractory multiple myeloma.
MM accounts for nearly 2% of all new-onset cancer patients and more than 2% of cancer deaths in the United States (see https://pubmed.
ncbi.
nlm.
nih.
gov/33498356/ for more information
).
About Genkai Bio
About Genkai Bio Founded in 2015, Yuanqi Biotech is an innovative pharmaceutical company
dedicated to the development of tumor cell immunotherapy products with independent innovation technology platform.
Up to now, the company has applied for 91 patents (including PCT) and obtained 10 authorizations
.
With the mission of developing drugs with affordable potency for unmet clinical needs around the world, Primeval Biotech has independently innovated and built a number of patented technology platforms such as Ori Ab and Ori®®CAR based on tumor cell immunotherapy, and has broken through the efficacy
bottleneck of CAR-T in the treatment of solid tumors from the aspects of antibody engineering construction technology, tumor immune microenvironment regulation, T cell infiltration and killing ability 。 The exploratory clinical research data of the first CAR-T product targeting GPC-3 developed by the company was positive and unveiled at ASCO 2021, and obtained the IND clinical trial approval of the NMPA in September this year; The first self-developed immune checkpoint (PD-L1/4-1BB) bispecific antibody drug YN051 (ATG101) was authorized to Antengene (B.
6996) for continued development with an initial payment + milestone of $142 million, and the project has obtained registration clinical trial approval in Australia, the United States and China, and completed the first patient administration
in Australia and China.
At present, GenQi Biotech has more than 10 cell drug pipelines for cancer treatment
.
Focus on liver cancer, ovarian cancer, gastric cancer, cervical cancer, non-small cell lung cancer, multiple myeloma and other indications
with a wide range of treatment needs.
Adhering to the corporate vision of "becoming the world's leading creator of new oncology immunotherapy drugs driven by innovation", Yuanqi Biotech has established an international product development and operation management team, built production facilities and quality testing and management systems in line with GMP specifications, and continuously explored and developed innovative tumor cell immunotherapy drugs with good curative effect, differentiation and affordable cost through independent innovation technology platforms, and strived to continuously open up new bureaus
in the development opportunities of "innovative drugs, made in China".
In July this year, Genesis announced the completion of a Series B financing
with a total amount of more than US$120 million.
