This week, many domestic pharmaceutical companies have ushered in new clinical progress in new drugs!

【Pharmaceutical Network Industry News】In the increasingly crowded R&D track and increasingly fierce competition, a large number of pharmaceutical companies are actively responding to national policies, constantly adapting to the higher requirements brought by industrial changes, and continuing to steadily promote scientific and technological innovation and internationalization strategies
.
Affected by this, the research and development of drug clinical trials is also accelerating, and many pharmaceutical companies have reported new progress
in clinical trials this week.
CStone On November 11, CStone announced that the GEMSTONE-303 study of sugemalimab injection combined with chemotherapy for the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma with unresectable PD-L1 expression ≥5% achieved one of the primary endpoints: progression-free survival ("PFS"
).
。 The GEMSTONE-303 study is a multicenter, randomized, placebo-controlled, Phase III registrational clinical trial designed to evaluate the efficacy and safety
of the combination of CAPOX ® chemotherapy (oxaliplatin + capecitabine) as a first-line treatment for locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that cannot be resected in ≥5% of unresectable PD-L1 。 Ascentage Pharmaceuticals On November 10, Ascentage Pharmaceuticals announced that APG-5918, a class 1 embryonic ectoderm development protein (EED) inhibitor under development, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and will carry out phase I clinical trials
for the treatment of advanced solid tumors or hematologic malignancies.
This is a multicenter, open-label Phase I dose-escalation and dose-expansion clinical trial designed to evaluate the safety, pharmacokinetics, and efficacy
of oral administration of APG-5918 in patients with advanced solid tumors or hematologic malignancies.
Prior to this, the investigational variety has been approved in the United States for clinical trials for advanced solid tumors or hematological tumor indications, which is another major achievement of the company's "Sino-US dual report" strategy, basically realizing the simultaneous advancement
of China and the United States.
Chengda Biotech On November 8, Chengda Biotech announced that the 13-valent pneumococcal conjugate vaccine jointly developed by the company and Bowo Biotech has completed the preparation of phase I clinical trial and officially entered phase I clinical trial
.
The 13-valent pneumococcal conjugate vaccine is mainly used in infants and children, and after vaccination, it can produce an immune response and prevent invasive diseases caused by pneumococcus (including bacteremic pneumonia, meningitis, sepsis, and bacteremia).

In addition, the ACYW135 meningococcal polysaccharide conjugate vaccine developed by the company was approved by the State Food and Drug Administration for clinical trials
.
Chenxin Pharmaceutical News on November 8, Chenxin Pharmaceutical announced that the company's WXSH0208 tablets have recently been approved by the State Food and Drug Administration and will carry out clinical trials
in the near future.
WXSH0208 tablets are influenza virus RNA polymerase inhibitors, which can block the transcription and replication of viral RNA, inhibit the proliferation of influenza virus, and are clinically intended for the treatment
of influenza A and B.
Upon inquiry, the domestic similar product is mabaloxavir tablets developed by Roche Pharmaceutical, which was approved for marketing by the State Food and Drug Administration in April 2021, and the PDB sample database shows that the cumulative sales in the first half of 2022 were about 3.
45 million yuan
.
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.
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Clinical trial is a very important part of new drug research and development, and it is also an indispensable link
for every new drug before it 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 continuous standardization of the clinical development of innovative drugs, the clinical practice of new drugs of major pharmaceutical companies is accelerating
.
According to statistics, since 2016, the number of clinical registrations of new drugs in China has been growing rapidly, reaching 1490 in 2021, with a year-on-year growth rate of 47.
96%, and an average compound growth rate of 35.
54%
from 2016 to 2021.
From the current point of view, the enthusiasm of domestic pharmaceutical companies to innovate is still very high, and the number of clinical trials is also continuing to grow, in this regard, the industry expects that the number of innovative drugs approved in China will also show an increasing trend in the future, helping China's pharmaceutical innovation industry to achieve further development
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.