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Japanese pharmaceutical company’s “COVID-19 prevention drug” receives FDA approval

On June 1, Shionogi & Co., Ltd. of Japan announced that the U.S. FDA had approved its oral antiviral drug XOCOVA (ensitrelvir) for post-exposure prophylaxis against COVID-19. This is currently the first and only oral post-exposure prophylaxis drug approved in the U.S. market. Ensitrelvir is a 3CL main protease inhibitor targeting SARS-CoV-2 , jointly developed by Hokkaido University and Shionogi & Co., Ltd. This drug selectively inhibits the activity of the main protease essential for viral replication, blocking viral amplification in the body. Ensitrelvir is administered orally as a single agent . The FDA approval was based on the results of the global, multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial SCORPIO-PEP . The study enrolled nearly 2,400 household contacts living with COVID-19 patients in the United States, Argentina, Japan, South Africa, and Vietnam. Participants began taking medication within 72 hours of the index case developing symptoms. Data from the ...
- Source: drugdu
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- June 4, 2026
Bristol-Myers Squibb’s new anticancer drug is proposed to be included in the priority review process

On June 3, the Center for Drug Evaluation (CDE) published a notice on its website stating that Bristol-Myers Squibb’s (BMS) Mezigdomide capsules are proposed for inclusion in the priority review and approval process. The proposed indication is for use in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received lenalidomide and anti-CD38 monoclonal antibody therapy. It is understood that this drug was recently granted Breakthrough Therapy designation by the CDE. Multiple myeloma is a difficult-to-cure hematologic malignancy, and even after multiple lines of treatment and achieving remission, almost all patients eventually relapse. With each line of treatment, the patient’s response rate to subsequent therapies and the duration of remission gradually decrease, which is a core challenge in the treatment of multiple myeloma. At the ASCO 2026 Annual Meeting, Bristol-Myers Squibb announced positive breakthrough results from the Phase III SUCCESSOR-2 ...
- Source: drugdu
- 65
- June 4, 2026
Pharmtech Ingredients

Organiser：ITE Group Time：November 24–27, 2026 Address：Crocus-Expo IEC, Krasnogorsk, 65–66 km Moscow Ring Road, Russia Exhibition hall：Crocus-Expo IEC Product range: Pharmaceutical Machinery: Formulation production equipment, pharmaceutical water systems, refrigeration equipment, traditional Chinese medicine processing equipment, etc. Packaging Equipment & Materials: Blister packaging machines, filling machines, tablet press machines, labeling machines, inkjet coders, anti-counterfeiting printing & packaging production lines, barcode composite technology equipment, self-adhesive label printing & packaging equipment, plastic packaging products, container forming-filling-sealing machines, cartoning machines, pouch packaging machines, multi-function bottle packaging machines, glass packaging products & pharmaceutical packaging material production equipment, etc. Laboratory Equipment / Analytical & Testing: Laboratory equipment & instruments, laboratory consumables, chemical reagents, biochemical/analytical instruments, biotechnology analytical & testing instruments, pharmaceutical testing equipment, food analysis & testing instruments, pharmaceutical industry analytical instruments, etc. Fluid Equipment: Sanitary pumps, valves, fluid engineering, pipes & fittings, microfiltration, ultrafiltration, etc. Cleanroom Systems: Cleanroom air conditioning equipment, cleanroom workstations/benches, cleanroom equipment, ...
- Source: drugdu
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- June 4, 2026
【EXPERT Q&A】What certifications are required for the export of medical device products to Russia? How to do it?

Drugdu.com expert’s response: Core Conclusion: To export medical devices to Russia, you must obtain two things — a Medical Device Registration Certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare), and an EAC Certificate of Conformity (COC or DOC). The registration certificate is the prerequisite to sell; the EAC is the customs clearance pass. Both are mandatory. I. What Certifications Are Required 1. National Medical Device Registration Certificate (Most Critical — Must Have) This is a registration certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare). All medical devices (Class 1, 2a, 2b, 3) must have this certificate to be sold in Russia. Without it, import and sale are prohibited. The certificate is typically valid permanently but requires periodic maintenance. 2. EAC Certificate of Conformity (Mandatory for Customs Clearance) Medical devices are high-risk products, so they follow the EAC Certificate of Conformity (COC) pathway, not DOC. Samples must ...
- Source: drugdu
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- June 3, 2026
Chia Tai Tianqing Pharmaceutical Group and Shionogi have collaborated on a major project, Xinpuluo® (Nadimethicone), which has been approved for marketing in China.

On May 29, the official website of the National Medical Products Administration (NMPA) showed that Naldemedine (generic name: Naldemedine tosylate tablets, trade name: Symproic® ) was approved for marketing for the treatment of opioid-induced constipation (OIC) in adults [ 1] . The approval of this innovative drug will provide patients suffering from OIC with a new treatment option to improve their quality of life (QOL) and promote the overall improvement of the level of supportive care for tumors in China. In January 2025, Chia Tai Tianqing Pharmaceutical Group, a core enterprise of China Biopharmaceutical (1177.HK), signed an agreement with Shionogi to obtain the exclusive marketing rights of Naldemedine in mainland China. Nadecamide is the world’s first approved oral selective peripheral μ-opioid receptor antagonist. By blocking the binding of opioids to μ receptors in the intestine, it directly restores the normal peristaltic rhythm and intestinal fluid secretion function, thus reversing the ...
- Source: drugdu
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- June 2, 2026
The first domestically produced HER2 bispecific antibody! Anituzumab from KNJ Pharmaceutical and CSPC Pharmaceutical Group has been approved for marketing

On May 28, the NMPA announced that it had approved the marketing of Anituzumab Injection (trade name: Enituzumab) submitted by Shanghai Jinmante Biotechnology through the priority review and approval procedure. This product, in combination with chemotherapy, is indicated for the treatment of locally advanced or metastatic HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing therapy . Anitumumab (KN026) was originally developed by KNJ Biopharma as a HER2 bispecific antibody that binds to two non-overlapping epitopes of HER2, blocking HER2 signaling. It enhances ADCC and CDC effects through antibody-induced receptor aggregation while downregulating cell surface HER2 receptors. In August 2021, KN026 was licensed to CSPC Pharmaceutical Group for a total transaction value of RMB 1 billion. Its wholly-owned subsidiary, Shanghai Jinmante Biotechnology, obtained exclusive rights to develop and commercialize KN026 in mainland China for breast cancer and gastric cancer indications. In November ...
- Source: drugdu
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- June 2, 2026
Within a single day, Hisun Pharmaceuticals received FDA approval for its cyclopropanol product and subsequently signed a global research and development agreement with Eli Lilly.

On June 1, 2026, Hisun Pharmaceutical Group Co., Ltd. (hereinafter referred to as ” Hisco “) issued two announcements that are significant enough to be recorded in the annals of Chinese innovative drug exports. The first announcement stated that Hisun Pharmaceutical Technology (Lhasa) Co., Ltd., a wholly-owned subsidiary of the company, officially signed a “Licensing and R&D Cooperation Agreement” with Eli Lilly and Company on May 29, 2026. The two parties will conduct strategic cooperation in the research and development of innovative drugs in multiple disease areas . The second announcement stated that Hisun’s independently developed Class 1 intravenous anesthetic innovative drug— Cipepofol Injection (Chinese trade name: 思舒宁®, English trade name: CYPSEDO)—officially received marketing approval from the U.S. Food and Drug Administration ( FDA ) for the induction of general anesthesia in adults. Cippofol thus became the first original innovative intravenous anesthetic drug from China to enter the international market. ...
- Source: drugdu
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- June 2, 2026
Xinhua Pharmaceutical’s Sevelamer Carbonate Dry Suspension Approved for Marketing

Recently, Xinhua Pharmaceutical’s sevelamer carbonate dry suspension (specifications: 0.8g; 2.4g ) received the Drug Registration Certificate issued by the National Medical Products Administration. The approval of this dosage form provides a new treatment option for patients with hyperphosphatemia due to chronic kidney disease ( CKD ). Hyperphosphatemia is a common complication in maintenance hemodialysis ( MHD ) patients and a challenge in their treatment. Studies show that almost all end-stage chronic kidney disease (CKD) patients have hyperphosphatemia, which is associated with adverse clinical outcomes. Therefore, it is recommended that CKD patients receive phosphorus-lowering therapy to achieve normal serum phosphorus levels. Sevelamer is a calcium-free, non-metallic phosphate binder. Its mechanism of action is to bind with phosphorus in the gastrointestinal tract, thereby reducing its absorption. Compared with metal-containing preparations such as calcium carbonate, it effectively avoids the risks of elevated blood calcium and metal accumulation. Sevelamer carbonate dry suspension is clinically ...
- Source: drugdu
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- June 2, 2026
CPhI India

Organiser：Informa Markets Time：November 23–26, 2026 Address：TCI Bus Stop, Bylappanapalya, No 7, Tumkur Rd, Madanayakahalli, Bengaluru, Madavara, Karnataka 562162, India Exhibition hall：Greater Noida Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretic & Analgesics, Tetracyclines, Amino Acids & Derivatives, Chloramphenicols, Digestive System Drugs, Other Anti-infectives, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular Drugs, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Drugs, Central Nervous System Drugs, Other Western Medicine Raw Materials Packaging Equipment: Pharmaceutical Machinery, Packaging Machinery, Packaging Materials, Drug Production Equipment & Technology, Drug Packaging Equipment, Drug Packaging Materials, Drug Production, Cleaning, Disinfection Systems & Laboratory Instrument Systems Pharmaceutical Products: Various Traditional Chinese Medicines, Western Medicines, New Drugs, Various APIs, Chemical Pharmaceuticals, Pharmaceutical Intermediates, Biopharmaceuticals, Traditional Medicines, Chinese Herbal Medicines, Herbal Medicines, Animal & Plant Extracts, Veterinary Drugs, Food Ingredients & Additives, etc. About CPhI India： CPhI India is the most influential pharmaceutical raw materials and machinery exhibition in South Asia. It ...
- Source: drugdu
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- June 2, 2026
【EXPERT Q&A】Is INMETRO certification required for the export of civilian masks to Brazil?

Drugdu.com expert’s response: In general, ordinary “civilian masks / non-medical masks” exported to Brazil are usually not regulated as medical devices or subject to INMETRO certification in the same way. It should also not be simply assumed that “all masks must obtain INMETRO certification.” The key is to first determine how the product is positioned in Brazil: I. If it is a civilian protective mask / non-medical mask This type of mask is generally closer to a consumer product or textile-based protective product. It should not claim medical use, surgical use, antiviral treatment, disease prevention, or other medical functions. The main compliance focus is usually on labeling, Portuguese instructions, materials, product safety, and the responsibility of the importer. Whether specific testing is required depends on the Brazilian importer and local regulatory requirements. II. If it is a medical surgical mask Then it is no longer an ordinary civilian mask. It ...
- Source: drugdu
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- June 1, 2026

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