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Eli Lilly’s telpopotamide approved for a new indication!

On August 28 (local time), Lilly announced that its blockbuster drug Tirzepatide (trade name: Mounjaro), a dual agonist of the GLP-1/GIP receptor, has been approved by the FDA for a new indication to reduce the risk of major adverse cardiovascular events (MACE, including CV death, non-fatal myocardial infarction, and non-fatal stroke) in patients with type 2 diabetes. Telpotriol is the first GLP-1R/GIPR agonist approved for this indication. The approval for this indication was based on topline results of cardiovascular outcomes from a head-to-head Phase 3 clinical trial (SURPASS-CVOT) comparing it to Eli Lilly’s GLP-1 receptor agonist Trulicity (dulaglutide, trade name in China: Duyida, approved in China in 2019). The SURPASS-CVOT study (Cardiovascular Outcomes Trial; NCT04255433/CTR20200498, co-led by Beijing Anzhen Hospital affiliated with Capital Medical University and Peking University People’s Hospital in mainland China, with 22 other Chinese hospitals participating) is an event-driven, randomized, double-blind, head-to-head phase 3 trial designed to ...
- Source: drugdu
- 46
- August 31, 2026
Livzon Pharmaceutical Group’s blockbuster Class 1 new drug has been approved for market launch!

With continuous investment in research and development, Livzon Pharmaceutical’s innovative pipeline is steadily delivering on its promises. It is reported that on August 27, the website of the National Medical Products Administration showed that Livzon Pharmaceutical’s Class 1 new drug, Lyconcitazone, was approved for marketing through the priority review and approval process. Lyconchitab is a dual-target inhibitor of IL-17A/F, which simultaneously blocks the interaction between IL-17A/F and its receptor, thereby inhibiting downstream inflammatory signaling pathways. It is indicated for multiple autoimmune and inflammatory diseases. This product has been approved for adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy. The announcement indicates that psoriasis is an inflammatory skin disease prone to relapse, induced by both genetic and environmental factors. There are approximately 125 million patients worldwide, with over 7 million in China, of whom plaque psoriasis accounts for about 80%. It is understood ...
- Source: drugdu
- 45
- August 31, 2026
【EXPERT Q&A】What on earth is the buyer looking at when he asks for the latest three batches of COA at once?

Drugdu.com expert’s response: When doing API foreign trade, you often encounter such inquiries. The customer has already confirmed the product name and specifications, and has obtained one copy of COA. After one or two rounds of communication, they put forward a new request: “Could you provide COAs for the latest three batches?” Some suppliers may feel confused: since one COA already shows all product indicators, why do customers need three consecutive batches? When a customer starts to review data of consecutive batches, their focus is no longer limited to confirming “whether you have this product”, but further judging whether this supplier can be included in their procurement system. I. One COA Shows Indicators, Multiple Batches Prove Stability A single COA can only reflect the test result of one specific batch. For customers who plan to make long-term purchases, this is far from sufficient. Taking APIs as an example, buyers will ...
- Source: drugdu
- 58
- August 31, 2026
【EXPERT Q&A】How to handle the production filing for medical devices?

Drugdu.com expert’s response: The medical device production filing is only applicable to the production activities of ‌Class I Medical Devices‌. Applications shall be submitted to the municipal drug regulatory department with districts where the enterprise is located, and the filing certificate can be issued on the spot if the conditions are met. The production of Class II and Class III medical devices does not apply to the filing system. It is required to apply for the official Medical Device Production License from the provincial drug regulatory department. I. Pre-application Preparation Requirements ‌Personnel Requirements‌: It is required to appoint qualified quality principals, technical principals, and at least 2 full-time inspectors. Personnel in relevant positions shall have a technical secondary school degree or above in medical device-related majors, and the personnel in other positions can be flexibly configured according to the actual situation of the enterprise. ‌Site & Facilities‌: The nature of the production ...
- Source: drugdu
- 56
- August 28, 2026
Cambodia Phar-Med Expo

Organiser：Minh Vi Exhibition & Advertisement Services Co., Ltd. Time：August 26 – 28, 2026 Address：Diamond Island Phnom Penh, Cambodia Exhibition hall：Diamond Island Convention & Exhibition Center Product range: Medical Devices & Equipment‌: Medical care auxiliary equipment, rehabilitation physiotherapy equipment, medical vehicles, beds and tables, surgical equipment, preventive medical equipment, diagnosis and examination equipment, monitoring equipment, therapeutic equipment, laboratory analysis equipment, first-aid and ambulance equipment, surgical equipment, diagnostic devices and supplies, analysis and control systems, orthopedic devices, ophthalmic instruments, otolaryngology equipment, dental supplies and devices, radiological medical equipment, medical reagents and devices, prosthetics and rehabilitation aids, healthcare products and devices, disinfection and sterilization equipment, traction devices, etc. ‌Medical Institution & Laboratory Technical Equipment‌: Laboratory furniture, laboratory automation and accessories, optical instruments, dressings and wound care materials, catheters, medical experimental analysis and diagnostic instruments, biopharmaceutical instruments, cell biology instruments, laboratory equipment and devices, biotechnology equipment, etc. ‌Medical Materials‌: First-aid kits, other medical ...
- Source: drugdu
- 55
- August 27, 2026
【EXPERT Q&A】Is it easy to obtain the Class II Medical Device Operation License?

Drugdu.com expert’s response: The overall difficulty of applying for the relevant operation qualifications for Class II medical devices is moderate. Most enterprises that meet the basic conditions can successfully complete the filing, with core difficulties concentrated in three aspects: personnel qualification, site compliance, and the implementation of system documents. 🎯 Core Factors Affecting Application Difficulty ‌Qualification Nature Difference‌: The operation of Class II medical devices is currently subject to the ‌filing system‌ in the vast majority of regions across the country, rather than a strict license approval system. Compared with the operation license for Class III medical devices, it has lower application thresholds and less strict review standards. Most regions support full-process online handling, and some regions even promise a processing time of only 1 working day. ‌Personnel Qualification Requirements‌: Enterprises are required to appoint full-time quality management personnel, who shall hold a college diploma or corresponding professional title in ...
- Source: drugdu
- 69
- August 26, 2026
DUPHAT

Organiser：INDEX Conferences & Exhibitions Time：August 25 – 27, 2026 Address：Sheik Zayed Road Convention Gate Dubai UAE – United Arab Emirates Exhibition hall：Dubai World Trade Centre Product range: Finished Pharmaceuticals: Various OTC and prescription drugs, Chinese patent medicines, Western medicines, new drugs, specific medicines, biopharmaceuticals, traditional Chinese medicines, herbal raw materials, various pharmaceutical raw materials, chemical pharmaceuticals, pharmaceutical intermediates and other medical products Pharmaceutical Raw Materials (Intermediates): 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, other Western pharmaceutical raw materials Excipients and Dosage Forms: Excipients, glidants, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrants, coating materials, surfactants, opacifiers, flavors, filter aids, stabilizers, lubricants, plasticizers, solvents, corrigents, colorants, clarifying agents, pH regulators, others Pharmaceutical Technology: Pharmaceutical production equipment and technologies, pharmaceutical packaging equipment, cleaning ...
- Source: drugdu
- 63
- August 24, 2026
【EXPERT Q&A】For new API suppliers joining the platform, should they choose “popular varieties” or “varieties with the most complete data” for their first batch of products?

Drugdu.com expert’s response: When many API suppliers first settle on a platform, they will encounter a common dilemma: which products should be uploaded as the first batch? Some enterprises prioritize popular varieties. Their reasoning is straightforward: these products are actively sought after in the market, boast higher search volumes, and have a greater chance of being noticed by buyers. Other enterprises prefer to upload varieties with the most complete documentation first. These products come with full COAs, specification sheets, GMP documents, DMF status statements, and even proven export experience. While they may not be the current top trending items, the enterprise can respond quickly and professionally whenever a buyer makes an inquiry. Neither approach is inherently wrong. The problem is that if you only focus on “popularity”, you will lack supporting documentation later, and inquiries will easily stall at the first round of communication. If you only select “fully documented ...
- Source: drugdu
- 88
- August 24, 2026
【EXPERT Q&A】How can clinical evaluations be carried out efficiently under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR Regulation, the core of efficiently carrying out clinical evaluation is to avoid repeated rectification in the later stage and greatly shorten the compliance cycle through advance planning, process standardization and pre-risk control. Below are the directly implementable efficient methods: 1. Build a Standardized Clinical Evaluation Plan (CEP) in Advance ‌Clarify core elements‌: Directly anchor the general safety and performance requirements supported by clinical data, the precise target patient population of the product, and quantifiable clinical benefit indicators in the plan to avoid repeated supplementation in subsequent stages. ‌Align compliance boundaries in advance‌: Proactively align with the requirements of MDR Annex XIV and MDCG 2021-6 guideline, so as to avoid common problems caused by missing plan elements from the very beginning. ‌Reserve a gap prediction session‌: Preset the execution nodes for literature retrieval and data assessment in advance, to identify potential clinical evidence gaps ...
- Source: drugdu
- 96
- August 21, 2026
CPhI Korea

Organiser：Informa Markets Time：August 25 – 27, 2026 Address：COEX Convention & Exhibition Center Exhibition hall：513 Yeongdong-daero, Gangnam District, Seoul, Republic of Korea Product range: Active Pharmaceutical Ingredients (APIs)‌: Vitamins, Hormones, Sulfonamides, Antipyretic Analgesics, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-Infective Agents, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Western Pharmaceutical Raw Materials ‌Excipients and Dosage Forms‌: Excipients, Glidants, Enteric-Coating Materials, Antioxidants, Sweeteners, Penetration Enhancers, Preservatives, Disintegrants, Coating Materials, Surfactants, Opacifiers, Flavors, Filter Aids, Stabilizers, Lubricants, Plasticizers, Solvents, Flavor Correctors, Colorants, Clarifying Agents, pH Regulators, Others ‌Natural Extracts‌: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Raw Materials, Functional Food Raw Materials, Health Supplement Raw Materials, Nutraceutical Raw Materials, Dietary Supplements, Dietary Fiber, Cosmetic Raw Materials About CPhI Korea ： CPhI Korea was first launched in 2014. Adopting an integrated model that organically combines exhibitions, ...
- Source: drugdu
- 67
- August 20, 2026

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