media – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】How should we view the consistency between generic drugs and original research drugs?

Drugdu.com expert’s response: The consistency between generic drugs and originator drugs is a crucial issue in the pharmaceutical field, with its core lying in assessing whether generic drugs achieve equivalent levels in terms of quality, efficacy, and safety compared to originator drugs. This issue not only concerns patients’ rights to medication but also affects the balance between innovation and accessibility in the pharmaceutical industry. The following analysis unfolds from four dimensions: science, policy, economy, and society. I. Scientific Foundation: Technical Standards for Consistency Evaluation Pharmaceutical Equivalence：Generic drugs must be identical to originator drugs in terms of active ingredients, dosage forms, strengths, and routes of administration, and demonstrate consistency in physical and chemical properties through tests such as dissolution rate and content uniformity. This serves as the fundamental threshold for generic drug development. Bioequivalence (BE)：It is necessary to prove through human clinical trials or alternative methods (e.g., in vitro models) that ...
- Source: drugdu
- 30
- February 18, 2026
CPHI Middle East

Organiser：Informa Markets Time：May 11 – 13, 2026 Address：King Abdullah Rd, King Abdullah Dt., Riyadh 11564, Saudi Arabia Exhibition hall：Riyadh International Convention & Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracyclines, amino acids and their derivatives, chloramphenicols, digestive system drugs, other anti-infective agents, penicillins, aminoglycosides, lincomycins, cardiovascular system drugs, antiparasitic drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, and other Western medicine raw materials. Pharmaceutical Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, production equipment and technology for pharmaceuticals, pharmaceutical packaging equipment, pharmaceutical packaging materials, systems for pharmaceutical production, cleaning, disinfection, and laboratory instrumentation. Pharmaceutical Products: Various traditional Chinese patent medicines, Western medicines, new drugs,特效 drugs (special-effect drugs), various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal and plant extracts, veterinary drugs, food ingredients and additives, etc. About CPHI Middle East： The CPhI Middle East in Riyadh, ...
- Source: drugdu
- 38
- February 17, 2026
【EXPERT Q&A】What should be noted when registering medical device products for the first time?

Drugdu.com expert’s response: I. Regulatory Framework and Product Classification 1. Clarify Regulatory Requirements Domestic Registration: Comply with China’s Medical Device Supervision and Administration Regulations, Medical Device Registration and Filing Measures, etc. Export Compliance: Meet target country/region standards (e.g., EU CE, U.S. FDA). Key Point: Regulations are frequently updated; track changes via the NMPA website or professional agencies. 2. Accurate Product Classification Classify risk levels per China’s Medical Device Classification Catalog: Class I (low risk), Class II (moderate risk), Class III (high risk). Registration processes vary significantly by class. Recommendation: Use the NMPA’s “Medical Device Classification Determination” system for uncertain cases. For innovative products, prepare for the “Special Approval Pathway for Innovative Medical Devices.” II. Technical Documentation and Testing 1. Prepare Complete Technical Files Product Technical Requirements (CTD): Detail performance metrics (e.g., filtration efficiency for surgical masks), testing methods, and structural composition. Ensure quantifiable, verifiable metrics aligned with national standards (e.g., GB, YY series). ...
- Source: drugdu
- 49
- February 16, 2026
Rising Star in Oral Weight Loss! Hengrui’s GLP 1R/GIPR Agonist Succeeds in Phase II Study

On February 10, 2026, Hengrui Pharmaceutical and Kailera Therapeutics (US) jointly announced positive top-line results from a Phase II clinical trial (NCT06841445) of Remputeptide Tablets (HRS9531), their investigational GLP 1/GIP dual receptor agonist, in Chinese adults with obesity. Data showed that at Week 26, mean body weight reduction in the highest dose group reached 12.1%, with no weight loss plateau observed. Up to 38.6% of participants achieved at least 15% weight loss, while the incidence of gastrointestinal adverse events was maintained at a low level. This breakthrough marks important progress in the global development of oral multi target weight loss drugs. With its convenient once daily oral administration and robust efficacy data, Remputeptide Tablets is expected to offer a new therapeutic option for patients with obesity that may surpass injectable formulations. It also adds a key competitive asset to Hengrui’s global strategic layout in metabolic diseases. 1 Remputeptide: Dual pathway ...
- Source: drugdu
- 56
- February 13, 2026
adjuvant therapy for breast cancer

On February 12, Daiichi Sankyo announced that its injectable detrastuzumab (Uroder®, DS-8201a, T-DXd) has been approved for inclusion in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of adult patients with HER2-positive breast cancer who still have residual invasive lesions after neoadjuvant anti-HER2 therapy. Detrastuzumab was developed by Daiichi Sankyo and co-developed by Daiichi Sankyo and AstraZeneca.A jointly developed HER2-targeting antibody-drug conjugate (ADC). https://finance.eastmoney.com/a/202602123648930874.html
- Source: drugdu
- 56
- February 13, 2026
The approval of telpopril monotherapy for type 2 diabetes has driven an upgrade in the management paradigm

　　According to this newspaper, in current clinical practice, the treatment of type 2 diabetes often relies heavily on the traditional approach of “gradually increasing medication.” Many patients only enter a more potent treatment phase after their blood sugar has been poorly controlled for a long time and the risk of complications has gradually accumulated. 　　However, in recent years, discussions surrounding early diabetes management have been undergoing a significant shift. A growing body of research suggests that the choice of treatment starting point not only affects short-term glycemic control but also profoundly relates to patients’ long-term complication risk and overall prognosis. Clinical management strategies for type 2 diabetes are shifting from a “late-stage reinforcement” approach to a new paradigm of “intervention at the starting point.” 　　February 11th, ReiThe innovative dual-target drug Mufengda® (Telborpeptide Injection) has been approved by the China National Medical Products Administration for monotherapy in adults with type 2 ...
- Source: drugdu
- 53
- February 13, 2026
Oral insulin launch fails; China Resources Pharmaceutical plans to sell Tianmai Biotechnology

On February 9, China Resources Pharmaceutical (03320.HK) issued an announcement on the Hong Kong Stock Exchange, stating that its wholly-owned subsidiary, China Resources Pharmaceutical Investment Co., Ltd., plans to sell its 17.87% stake in Hefei Tianmai Biotechnology Development Co., Ltd. (hereinafter referred to as “Tianmai Biotechnology”) through a public listing on the Shanghai United Assets and Equity Exchange, with a listing price of RMB 1.42 billion. Looking back at the history of cooperation between China Resources Pharmaceutical and Tianmai Biotechnology, their partnership began in 2016, when the number of diabetes patients in China continued to rise, leading to a surge in demand for insulin as a core treatment drug. At the same time, China Resources Pharmaceutical was also seeking to expand into the biopharmaceutical field. Against this backdrop, China Resources Pharmaceutical signed a strategic agreement in December 2016 to acquire a 20% stake in Tianmai Biotechnology, thus officially entering the ...
- Source: drugdu
- 48
- February 13, 2026
Hanyu Pharmaceutical’s glatiramer acetate injection receives FDA approval in the United States.

Shanghai Securities News China Securities(Reporter He Xinyi) On the evening of February 12, Hanyu Pharmaceutical…The announcement stated that the company received an abbreviated new drug application certificate for glatiramer acetate injection from the U.S. Food and Drug Administration (FDA). The announcement indicates that glatiramer acetate is an immunomodulatory drug used to treat relapsing-remitting multiple sclerosis (MS). It is a synthetic polypeptide preparation that modulates abnormal autoimmune responses by mimicking the structure of myelin basic proteins, thereby reducing the attack on the myelin sheath of the central nervous system. Hanyu Pharmaceutical stated that the approval of glatiramer acetate will further enrich the company’s overseas product pipeline and expand the company’s pharmaceutical market in the United States. The company will actively promote the sales of the drug in overseas markets, thereby positively promoting the company’s future performance growth and industry position. https://finance.eastmoney.com/a/202602123649504078.html
- Source: drugdu
- 53
- February 13, 2026
Global ADC market size $16.5 billion

20 new ADC drugs worldwide reached US$16.51 billion , a year-on-year increase of 27% , maintaining rapid growth. Six of these ADCs are blockbuster products with sales exceeding US$1 billion, including four super blockbuster products with sales exceeding US$2 billion. Enhertu continues to maintain its monopoly position, and its indications continue to expand.Datroway saw a 50% quarter-over-quarter increase and significantly raised its sales forecast.Padcev has performed exceptionally well in the US and European markets, with growth exceeding expectations.Roche’s T-DM1 has maintained steady growth, mainly due to the increase in adjuvant therapy for breast cancer.Polivy maintains rapid growth, solidifies its position as a leading DLBCL provider, and rapidly penetrates the market. Trodelvy is primarily marketed as a second-line treatment for triple-negative breast cancer, with first-line treatment expected to be approved in the second half of this year.Conclusion Chinese ADCs are playing an increasingly important role. BIC’s Trop2 ADC has been approved ...
- Source: drugdu
- 44
- February 13, 2026
A blockbuster hepatitis B drug with sales of 2.4 billion yuan is taking off for the second time.

According to the latest preliminary financial report released by Tebo Bio , the company continued its high growth momentum in 2025, with total operating revenue reaching RMB 3.696 billion, a year-on-year increase of 31.18%; net profit attributable to the parent company was RMB 1.038 billion, a year-on-year increase of 25.39%. This achievement was mainly due to the continued increase in sales volume of its core product, Pegbin , and the incremental contribution brought by the launch of the new product, Yipeisheng . It is worth noting that Pegbin , the company’s flagship product, achieved sales of RMB 2.447 billion in 2024 , with a gross profit margin of an astonishing 96.22% . Building on this already substantial base, stable growth was achieved again in 2025 (the preliminary earnings report did not disclose 2025 sales figures). The surge in popularity of Pegasys is no accident. As the world’s first 40kD polyethylene ...
- Source: drugdu
- 44
- February 13, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.