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The Chinese Pharmacopoeia 2025 has introduced significant revisions to the 9101 Guidelines for Validation of Analytical Methods further promoting the application of statistics in analytical method validation.
September 12, 2025
by Xing Xing
Assesses continuous manufacturing (CM) in pharma green transition, comparing efficiency gains with traditional production amid tech/regulatory barriers and ESG impacts.
September 5, 2025
by Aiden
Profiles 16 China-made blockbuster drugs exceeding ¥1B sales, highlighting intense PD-1 competition, EGFR tech innovation, and bispecific antibody/non-oncology surge.
September 5, 2025
by Lezhi
In 2024, the "Billion-Yuan Club" of made-in-China first-in-class new drugs expanded to 16 members.
September 5, 2025
by lezhi
In recent years, the green transformation of the pharmaceutical industry has become a widely discussed topic, with continuous manufacturing emerging as one of the key technologies driving this shift.
September 5, 2025
by Aiden
As the "low-hanging fruit" in drug discovery becomes increasingly scarce, pharmaceutical companies are shifting their focus toward novel targets. At this year's AACR Annual Meeting, AstraZeneca unveiled preclinical data for AZD0516, a drug candidate targe
July 11, 2025
by Xiaobin
How did MNCs fare in the oncology field during Q1 of this year?
June 4, 2025
by Xiaobin
This article describes successful practices from the United States 505(b)(2) pathway and analyzes R&D status of China's modified new drugs.
April 28, 2025
by Kevin
PD-(L)1 and VEGF (vascular endothelial growth factor) bispecific antibody therapies are considered a key direction for future tumor treatments, attracting increasing global interest due to their unique mechanism of action and promising clinical data.
April 28, 2025
by Kevin
On April 15, DualityBio, a rising star in the ADC field, was officially listed on the HKEX, marking one of the most high-profile IPOs in recent years in Chapter 18A Biotech Companies.
April 15, 2025
by Kevin
From 2016 - 2024, TCM new drugs made progress but lagged in sales. This article analyzes reasons and explores future directions.
March 14, 2025
by Xiao Yan
Over the past decade, China's innovative drug market has experienced remarkable transformation and growth. With the combined drive of policies, technology, and capital, China's innovative drug industry has entered a golden period of growth. This paper pro
March 14, 2025
by Kevin
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