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【EXPERT Q&A】Do IVD clinical trials need to include interference samples?

Drugdu.com expert’s response: The inclusion of interference samples is necessary in IVD (in vitro diagnostic) clinical trials. According to the requirements of the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, subjects enrolled should be considered for inclusion of samples that may interfere with the test. This requirement aims to ensure the accuracy and reliability of IVD reagents in clinical use by evaluating their performance under complex conditions through the inclusion of interference samples. In practical operations, the selection and preparation of interference samples need to follow certain methods. For example, samples near the upper and lower limits of the reference range and medical decision levels can be selected as test samples, with hemoglobin, rheumatoid factor, and other interferents added to clinical samples. The volume of added interferents should generally not exceed a certain proportion of the total sample volume to ensure the validity of the test. In addition, ...
- Source: drugdu
- 390
- February 3, 2025
A Global Breakthrough Battle for Chinese Innovative Drugs

On the evening of June 30, 2021, Eli Lilly (688578.SH) and ArriVent Biopharma, Inc. (hereinafter referred to as “ArriVent”) announced a deal regarding its core product, furmonertinib mesylate tablets (hereinafter referred to as “furmonertinib”). Eli Lilly granted ArriVent the exclusive development and commercialization rights of furmonertinib overseas (excluding the Chinese mainland, Hong Kong, Macau and Taiwan regions). Through this deal, Eli Lilly received an upfront payment of $40 million, with cumulative milestone payments for R & D and sales and sales royalties of no more than $765 million. More importantly, Eli Lilly acquired a certain percentage of ArriVent’s shares, and ArriVent became an associated company of Eli Lilly. At that time, Eli Lilly had just been listed on the Sci-Tech Innovation Board for half a year, and ArriVent was also a new company that had just completed its first round of financing, raising tens of millions of dollars. In the ...
- Source: drugdu
- 1,174
- February 2, 2025
“ Hainan Haiyao Announces Estimated 2024 Net Profit Loss of 900 to 1,300 Million Yuan”

“Hainan Haiyao (000566) has issued an announcement, expecting a net profit loss ranging from 900 million to 1,300 million yuan for 2024, compared with a loss of 106.4886 million yuan in the same period last year. The expected loss of non-recurring net profit is from 700 million to 1,000 million yuan, while in the same period last year, it was a loss of 410.1863 million yuan. The expected loss per basic share is from 0.6937 yuan/share to 1.002 yuan/share, as opposed to a loss of 0.0821 yuan/share in the same period last year. The operating income is expected to be between 1,000 million and 1,200 million yuan, compared with 1,480 million yuan in the same period last year. The main reasons for the performance changes: The estimated amount of impairment losses on assets and credit impairment losses in this reporting period is approximately -700 million yuan, mainly due to the ...
- Source: drugdu
- 327
- February 2, 2025
“Turning Ancient Classical Prescriptions into New Drugs, Shanghai’s First 3.1-Type New Chinese Medicine Approved for Marketing”

“Recently, the “Yiguanjian Granules” developed by Shanghai Kaibao Pharmaceutical Co., Ltd. were approved by the National Medical Products Administration for marketing, becoming the first 3.1-type new Chinese medicine in Shanghai derived from an ancient classical prescription. In 2018, the National Administration of Traditional Chinese Medicine, in conjunction with the National Medical Products Administration, announced the “Directory of Ancient Classical Prescriptions (First Batch)”, which included a total of 100 prescriptions, with “Yiguanjian” being listed among them. After more than 6 years of research and development, this classic prescription has regained new vitality and been transformed into a modern preparation with stable quality, good safety, and convenient administration. In recent years, the National Administration of Traditional Chinese Medicine has organized and promoted the research work on the key information verification of ancient classical prescriptions, and jointly with the National Medical Products Administration, announced three batches of the “Directory of Ancient Classical Prescriptions”, ...
- Source: drugdu
- 357
- February 2, 2025
Worst Single Quarter in Recent Years! “Medicine Maotai” Pien Tze Huang Enters a “Slow – down” Moment, Losing Nearly 170 Billion Yuan in Market Value

Recently, Pien Tze Huang’s 2024 performance report was released. In 2024, the company achieved total operating revenue of approximately 10.769 billion yuan, an increase of 7.06% compared with 10.058 billion yuan in the same period of the previous year. The net profit reached 2.974 billion yuan, an increase of 6.32% compared with 2.797 billion yuan in the same period of the previous year. In terms of performance growth rate, in 2023, Pien Tze Huang’s operating revenue increased by 15.69% year – on – year, and the net profit increased by 13.15% year – on – year. In 2024, the performance growth rate of Pien Tze Huang slowed down. Looking at single – quarter performance, in the fourth quarter of 2024, Pien Tze Huang achieved operating revenue of 2.32 billion yuan, a year – on – year decrease of 5.7%; the net profit was 290 million yuan, a year – on ...
- Source: drugdu
- 546
- February 2, 2025
Lepu Biopharma’s preclinical ADC drug goes international

On the morning of January 22, Lepu Biopharma (02157.HK) announced a global exclusive licensing agreement with ArriVent BioPharma, Inc. (AVBP.O, hereafter referred to as ArriVent) for an antibody-drug conjugate (ADC) called MRG007, aimed at gastrointestinal cancers. The company’s stock opened over 13% higher in the morning, and as of the time of publication, it rose 7.95% to HKD 2.58/share. According to the agreement, Lepu Biopharma grants ArriVent the global exclusive license to develop, manufacture, and commercialize MRG007 in regions outside Greater China (which includes mainland China, Hong Kong, Macau, and Taiwan). Lepu Biopharma will receive a total upfront payment of $47 million, with upcoming milestone payments, and up to $1.16 billion for development, registration, and sales-related milestone payments, as well as tiered royalties based on net sales outside Greater China. Lepu Biopharma announced that MRG007 showed strong anti-tumor activity in preclinical models of gastrointestinal cancers and demonstrated a high therapeutic ...
- Source: drugdu
- 271
- February 1, 2025
20-valent pneumococcal polysaccharide conjugate vaccine clinical research application accepted

Watson Bio (300142) announced on the evening of January 21 that the 20-valent pneumococcal polysaccharide conjugate vaccine jointly developed by the company and its subsidiaries Yuxi Watson Biotechnology Co., Ltd. and Yunnan Vaccine Laboratory Co., Ltd. applied to the National Medical Products Administration for clinical trials and recently obtained the “Acceptance Notice”. The 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) is independently developed by the company. It is an upgraded product developed on the basis of the company’s 13-valent pneumococcal polysaccharide conjugate vaccine that has been produced and marketed, covering more pneumococcal pathogenic serotypes. In addition, the company decided to terminate the clinical research related work of the DTaP-Hib quadruple vaccine. https://finance.eastmoney.com/a/202501213303737886.html
- Source: drugdu
- 274
- February 1, 2025
Baoji Pharmaceuticals submits listing application to the Hong Kong Stock Exchange, focusing on the research and development of large-scale biological drugs

According to the Hong Kong Stock Exchange’s disclosure on January 21, Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Baoji Pharmaceuticals”) submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities and Haitong International as joint sponsors. Since its establishment in 2019, the company has always focused on the research and development of large-scale biological drugs, and is committed to improving treatment standards by replacing biochemical extraction products derived from animal organs, blood or urine, or upgrading existing treatments in other ways. According to Frost & Sullivan, the combined potential market size of these four areas will exceed RMB 50 billion in 2033: (i) large-volume subcutaneous administration, (ii) antibody-mediated autoimmune diseases, (iii) assisted reproductive drugs, and (iv) transformative products that replace traditional biochemical products with recombinant biopharmaceuticals. As of the Latest Practicable Date, the Company has built a differentiated R&D pipeline covering the above four therapeutic ...
- Source: drugdu
- 469
- February 1, 2025
Liu Yongjun returns to Huapu Biotechnology as Chairman

On January 16, 2025, Huapu Biotechnology completed the company’s change registration, the board of directors was adjusted, and Liu Yongjun was appointed as the chairman. This is also the first time that Liu Yongjun has clearly announced his new destination since leaving Shiyao Group in December last year. Huapu Biotechnology was founded in 2001 and is located in Shijiazhuang, Hebei Province. Based on immunology, it focuses on the development of new drugs in the fields of tumors, infections, and autoimmune diseases. At present, a CpG technology platform has been established for the development of innovative vaccines, tumor immunotherapy, etc. Liu Yongjun was established as a scientific founder at the beginning of the company, and another scientific founder was Professor Chen Jianzhu. Wang Xinzhong, the founder of Fushengkang, served as the global R&D president and chief scientist of the company after the merger was completed. The three R&D experts are all ...
- Source: drugdu
- 328
- February 1, 2025
Trump signs executive order, US to withdraw from WHO

Soon after taking office for his second term, US President Donald Trump signed an executive order on Monday (January 20) directing the United States to withdraw from the World Health Organization (WHO), saying the agency had mishandled the Covid-19 pandemic and other international health crises. Trump said the WHO failed to act independently of “undue political influence from WHO member states” and also asked the United States to “unfairly pay huge fees” that were disproportionate to the amounts provided by other larger countries such as China. “The World Health Organization ripped us off, and everyone ripped off the United States. That won’t happen again,” Trump said as he signed an executive order to withdraw from the organization at the White House just hours after taking office. The WHO did not immediately respond to a request for comment. The move means the United States will withdraw from the UN health agency ...
- Source: drugdu
- 307
- February 1, 2025

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