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Clinical trials are very important in the process of new drug research and development, and are an indispensable link
before each new drug is approved for production and put on the market.
At present, under the background of innovation and upgrading at the core of building product competitiveness and the accelerating development of the innovative drug industry, the clinical practice of new drugs by domestic and foreign pharmaceutical companies is constantly unfolding
.
Recently, a large number of pharmaceutical companies have come with good news
in clinical trials.
For example, on December 6, biopharmaceutical company Nkarta announced the off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell candidate therapy NKX019 as new data
from a Phase 1 clinical trial for a single-dose treatment for relapsed or refractory non-Hodgkin lymphoma (NHL).
Analysis showed that up to 70% of patients achieved complete remission (CR).
On the same day, Novartis announced that its targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has achieved positive results in a Phase 3 trial for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated
with androgen receptor pathway inhibitors (ARPI).
。 The data showed that patients receiving Pluvicto achieved a statistically significant and clinically significant improvement
in radiographic progression-free survival (rPFS) compared with a cohort that changed the type of ARPI used.
On December 5, Innovent Biopharma Group and UNION therapeutics A/S announced that the first subject dosing
of the global Phase II inhibitor orismilast (Innovent R&D code: IBI353) in a phase I clinical study in healthy subjects in China 。 The study (CTR 20222393) is a Phase I dose-escalation clinical study administered multiple times in healthy subjects, with the primary objective of evaluating the pharmacokinetic (PK) characteristics, safety and tolerability of Chinese healthy subjects after multiple doses of orismilast, in order to support the subsequent clinical development
of orismilast in multiple indications such as psoriasis and atopic dermatitis (AD).
。 On December 4, GlaxoSmithKline announced positive results
from its Phase 3 trial of its anti-PD-1 antibody dostarlimab as a first-line therapy for adult patients with advanced or recurrent endometrial cancer in situ.
This scheduled interim analysis showed that the trial met the primary endpoint and that patients receiving dostarlimab combination therapy had statistically and clinically significant improvements
in progression-free survival (PFS) as assessed by the investigators 。 News on December 2, Simcere Pharmaceutical and Nanjing Ningdan New Drug Technology Co.
, Ltd.
cooperated with "Xianbixin sublingual tablets" for the treatment of acute ischemic stroke (AIS) multicenter, randomized, double-blind, parallel, placebo-controlled phase III clinical study has recently completed database locking (DBL), preliminary analysis shows that compared with placebo, Xianbixin sublingual tablets significantly improve the neurological function recovery and independent living ability of AIS patients after treatment, reaching the expected efficacy endpoint, and the safety is good
。 .
.
.
.
.
.
From the current point of view, although it is the end of the year, the enthusiasm of domestic and foreign pharmaceutical companies to innovate is still very high, and the number of clinical trials is also continuing to grow
.
The industry expects that in this context, pharmaceutical companies will continue to emerge more new achievements in new drug research and development in the future, benefiting patients
at home and abroad.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.