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Pharmaconex

Organiser：Informa Markets Time：September 1st – 3rd, 2026 Address：El-Nasr Rd Al Estad Nasr City Cairo Governorate Exhibition hall：Cairo International Convention Centre Product range: Vitamins, hormones, antipyretic analgesics, digestive system drugs, anti-infective drugs, antiparasitic drugs, cardiovascular system drugs, pharmaceutical intermediates Pharmaceutical packaging materials, PVC/PVDC composite sheets, PVC rigid sheets, PS sheets, packaging anti-counterfeiting technology information, labeling and sleeving technologies, labeling machines, packaging containers, form-fill-seal machines, wrapping machines, paper-based film packaging machinery, bag packaging machines, etc. Infusion equipment production lines, dryers, water treatment equipment, refrigeration compressors, distillation equipment, sterilization equipment, tablet presses, coating machines About Pharmaconex： The Pharmaconex – Egypt Cairo Pharmaceutical Raw Materials Exhibition is the most renowned exhibition focused on pharmaceutical raw materials and technologies in Egypt. It is hosted by Informa Markets, a world-famous British exhibition organizer with rich experience and strong capabilities in exhibition organization, and it holds great significance for enterprises looking to explore the Egyptian ...
- Source: drugdu
- 28
- September 1, 2026
Baoji Pharmaceutical’s HER2 bispecific antibody KJ015 received FDA approval in the United States, marking a key step in its internationalization strategy.

[Shanghai, China] Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Baoji Pharmaceutical”) recently announced that its Investigational New Drug (IND) application for KJ015, a subcutaneous formulation of a HER2-targeting bispecific antibody, was officially approved by the U.S. Food and Drug Administration (FDA) on August 21, 2026, authorizing it to conduct clinical trials in the United States. This is another significant milestone for KJ015, following its IND approval from the China National Medical Products Administration (NMPA) in December 2024 and the initiation of Phase I clinical trials in China in June 2025 . Powered by universal light chain technology: An antibody achieves dual blockade with Herceptin and Perjeta. KJ015 is an innovative subcutaneous formulation of a bispecific anti-HER2 antibody derived from universal light chain technology. It is designed with two Fab arms containing universal light chains, forming a near-native IgG1 structure. By maintaining high affinity for both epitopes simultaneously, KJ015 ...
- Source: drugdu
- 44
- August 31, 2026
Takeda’s first-ever innovative drug approved for market launch

On August 28, Takeda announced that Rusfertide (trade name: Mimrylo) has been approved by the FDA for the treatment of adult patients with polycythemia vera (PV). Rusfertide is a first-in-class hepcidin analogue , acquired by Takeda from Protector Therapeutics . It is designed to regulate iron distribution and excessive erythrocyte production in the body to control hematocrit (the ratio of red blood cells to total blood volume). The primary treatment goal for PV is to keep hematocrit below 45%. Takeda holds the exclusive global rights to develop and commercialize Rusfertide . This approval is supported by data from the global Phase III VEVERIFY study. This study was a randomized, multicenter, placebo-controlled clinical trial (n=293) designed to evaluate the efficacy and safety of rusfertide (once weekly, subcutaneously) in patients with PV. The primary endpoint of the study was response rate (the proportion of patients who did not require phlebotomy). The results ...
- Source: drugdu
- 40
- August 31, 2026
The FDA has accepted the application for a new indication for Shuwozhe®, for first-line monotherapy in EGFR exon20ins non-small cell lung cancer

On August 30, 2026, Dizhe Pharmaceuticals (stock code: 688192.SH) announced that its self-developed novel lung cancer targeted drug, Shuvozhe® (shuvotinib), has been accepted by the U.S. Food and Drug Administration (FDA) for a new indication marketing application (sNDA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). This application is based on the results of the Phase III international multicenter randomized controlled clinical trial “WU-KONG28”. This study aimed to evaluate the efficacy and safety of Shuwozhe® compared to platinum-based doublet chemotherapy in the first-line treatment of EGFR exon20ins NSCLC. The results showed that Shuwozhe® demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) compared to platinum-based doublet chemotherapy. Detailed data have been presented as a Breakthrough Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) ...
- Source: drugdu
- 40
- August 31, 2026
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
- 36
- 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
- 36
- 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
- 39
- 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
- 51
- 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
- 48
- 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
- 64
- August 26, 2026

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