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The snoring of 1 billion people can finally be cured! The FDA has accepted the marketing application for a new oral drug for obstructive sleep apnea.

If all goes well, a new drug for snoring will be approved early next year, potentially becoming the world’s first landmark drug targeting the neuromuscular causes of snoring . In July, Phase III clinical data of AD109 , a new oral drug for obstructive sleep apnea ( OSA ), was published in the American Journal of Respiratory and Critical Care Medicine . The data showed that the apnea-hypopnea index (AHI) decreased by 44.1% after treatment , and the oxygen depletion index and blood oxygen saturation were improved, indicating a significant improvement in the severity of OSA. picture AD109, developed by the US biotechnology company Apnimed , consists of the marketed drug atomoxetine and a novel isomer, R -oxybutynin , derived from the older drug oxybutynin. It works by modulating nerve signals, allowing patients to maintain airway tone during sleep and reducing the occurrence of sleep apnea. Its new drug application ...
- Source: drugdu
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- September 3, 2026
Biosimilar Export Accelerates! Jianyou’s Adalimumab Receives FDA Approval for Additional Manufacturing Site | Overseas Expansion News

On September 1, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (Jianyou, 603707.SH) announced that its subsidiary, Emerge Bioscience Pte. Ltd., recently received a letter from the U.S. Food and Drug Administration (FDA) approving an additional manufacturing site for adalimumab injection (40 mg/0.8 mL, single-dose) under BLA No. 761216. The approval authorizes production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. Adalimumab injection, a biosimilar, was first approved by the U.S. FDA on December 17, 2021. Its indications cover multiple autoimmune diseases including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The approval of the additional Nanjing manufacturing site further strengthens the product’s supply chain capabilities, providing more stable supply assurance for the U.S. market. Jianyou is an integrated pharmaceutical group focusing on R&D, production, and sales, with core business centered on heparin API and formulation supply. It has over 80 ...
- Source: drugdu
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- September 3, 2026
Beyond Glycemic Control! Lilly’s Tirzepatide Receives FDA Approval for Cardiovascular Risk Reduction | Approval Alert

On September 1, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) has officially approved tirzepatide (brand name: Mounjaro) for a new indication to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, in adults with type 2 diabetes at high risk for these events. With this approval, tirzepatide becomes the world’s first GIP/GLP-1 dual receptor agonist approved for this indication. Tirzepatide is an innovative dual-target metabolic drug that simultaneously activates GLP-1 and GIP receptors, offering multiple benefits including potent glycemic control, weight loss, and improvement of metabolic disorders. It was previously approved overseas for type 2 diabetes glycemic control and adult obesity or overweight management, with continuously expanding clinical applications. This cardiovascular protection indication approval is supported by data from the large-scale Phase 3 SURPASS-CVOT study involving over 13,000 participants, fully validating the drug’s cardiovascular benefit in diabetes ...
- Source: drugdu
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- September 3, 2026
First New Therapy in Nearly 30 Years! FDA Approves Besremi for Essential Thrombocythemia | Approval Alert

On September 1, the U.S. Food and Drug Administration (FDA) approved PharmaEssentia’s Besremi (ropeginterferon alfa-2b) for adults with essential thrombocythemia (ET). This marks the first new FDA-approved treatment for ET in nearly 30 years. Essential thrombocythemia is a type of myeloproliferative neoplasm in which the bone marrow produces too many platelets, increasing the risk of potentially serious blood clots, including strokes, heart attacks, and pulmonary embolisms. Some patients may also experience abnormal bleeding or an enlarged spleen. Besremi is a long-acting interferon therapy previously approved for polycythemia vera (PV), another myeloproliferative neoplasm characterized by overproduction of red blood cells. This expanded approval allows use of Besremi in adults with ET regardless of disease status or genetic subtype, including newly diagnosed patients who have not previously received cytoreductive therapy. The approval is based on results from the global Phase 3 SURPASS-ET study, which compared Besremi with anagrelide in ET patients who ...
- Source: drugdu
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- September 3, 2026
Filling Domestic Gap! Hengrui’s First Long-Acting Insulin Ruihengying® Launches Online on Sept 1 | Industry News

On September 1, Hengrui Pharmaceuticals’ self-developed Class 1 innovative biologic, insulin degludec injection (brand name: Ruihengying®), officially launched on the Ali Health platform. This product is the first domestically developed long-acting insulin analog in China, indicated for the treatment of adult type 2 diabetes. From receiving NMPA marketing approval at the end of July to online launch, it took only one month, which industry observers say reflects the accelerating flow of innovative drugs from regulatory approval to patient access in China. Insulin degludec injection (development code: INS068) is a long-acting basal insulin with durable and stable action, with cumulative R&D investment of approximately 544 million yuan. Two pivotal Phase III clinical studies showed that for Chinese type 2 diabetes patients, the drug’s glycemic control is comparable to insulin glargine, with a lower risk of nocturnal hypoglycemia than the comparator, directly addressing a long-standing clinical pain point and better meeting the ...
- Source: drugdu
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- September 3, 2026
Medical Fair Asia

Organiser：Messe Düsseldorf GmbH Time：September 9th – 11th, 2026 Address：10 Bayfront Avenue, Singapore, Singapore Exhibition hall：Sands Expo & Convention Centre Product range: Emergency room equipment Building technology and services Communication and information technology Dental equipment and supplies Diagnosis, disinfection and processing systems Electronic medical instruments, medical technology Catering and kitchen equipment Textiles and laundry services Medical furniture and equipment Laboratory equipment Medical consumables Ophthalmic products Rehabilitation equipment, orthopedic consumables Pharmaceutical products Services and publications About Medical Fair Asia： Medical Fair Asia, founded in 1997, is the largest medical industry exhibition in Singapore and one of the most well-known medical exhibitions in Asia. It showcases a full range of products and services covering the entire field from outpatient treatment to inpatient care, with exhibits including medical devices, medical furniture and equipment, medical site construction technology, and medical facility management. Both exhibitors and visitors at Medical Fair Asia have achieved fruitful ...
- Source: drugdu
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- September 3, 2026
Eli Lilly’s new acquisition

Lilly recently announced a definitive agreement to acquire biotechnology company Merida Biosciences for up to $2.875 billion. The transaction includes upfront payments and potential milestone payments and is expected to close in the fourth quarter of 2026. Founded in 2022 and headquartered in the United States, Merida Biosciences completed a $121 million Series A funding round in 2025. The company is developing engineered biologics with a specific antigen at one end of its molecular structure that binds to pathogenic antibodies, and an engineered Fc fragment at the other end that mediates endocytosis and degradation by hepatocytes, thereby selectively clearing pathogenic autoantibodies while preserving normal immune function. This mechanism targets antibody-driven autoimmune diseases and allergic diseases. Merida’s first pipeline product, MER511, is currently in Phase I clinical trials for the treatment of Graves’ disease and thyroid eye disease. Graves’ disease is an autoimmune thyroid disorder affecting approximately 3 million people in ...
- Source: drugdu
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- September 2, 2026
World’s First Oral IL-23R Peptide Drug! Janssen’s Icotrokinra (艾特雅®) Approved in China for Psoriasis | Approval Alert

On August 27, 2026, Johnson & Johnson announced that its interleukin-23 (IL-23) receptor antagonist icotrokinra (艾特雅®, 盐酸伊可白滞素片) has been officially approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older weighing at least 40 kg. Icotrokinra is the first and currently only targeted oral peptide drug that precisely blocks the IL-23 receptor. The Center for Drug Evaluation of the NMPA granted it priority review qualification in November 2025. In four Phase III clinical studies enrolling a total of 2,500 patients, icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile. In the head-to-head superiority study, approximately 70% of patients achieved complete or almost complete skin clearance (IGA 0/1) at Week 16, and 55% achieved a Psoriasis Area and Severity Index improvement of ...
- Source: drugdu
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- September 2, 2026
First Domestic FGFR1/2/3 Inhibitor! HUTCHMED’s ATLED® (Fanregratinib) Receives Conditional NMPA Approval | Approval Alert

On August 28, 2026, HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453) has been granted conditional approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®. Intrahepatic cholangiocarcinoma is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2%-15.0% of primary liver cancers and ranking as the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has been continuously rising, with a 5-year overall survival rate of approximately 9%. Approximately 10%-15% of intrahepatic cholangiocarcinoma patients worldwide harbor FGFR2 fusions or rearrangements. This approval is supported by data from the Phase II registration cohort ...
- Source: drugdu
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- September 2, 2026
Simcere Zaiming Signs Exclusive Licensing Agreement with Roche for Global Development of Tri-Specific Antibody SIM0660 | Partnership News

On September 1, 2026, Simcere Zaiming, the anti-tumor innovative drug subsidiary of Simcere Pharmaceutical Group (02096), announced that it has signed an exclusive licensing agreement with Roche for the global development and commercialization of SIM0660, a CD79a/CD19/CD3 tri-specific antibody with therapeutic potential for multiple B-cell-related diseases. Under the terms of the agreement, Roche will receive exclusive worldwide rights for the development, manufacturing, and commercialization of SIM0660. Simcere Zaiming will be eligible to receive total transaction payments of up to $1.53 billion, including a $75 million upfront payment. Based on future net sales, Simcere Zaiming may also be entitled to tiered double-digit royalties. SIM0660 is a tri-specific antibody developed using Simcere Zaiming’s T-cell engager (TCE) multi-specific antibody technology platform. The molecule fuses a CD3-binding T-cell engager arm with binding domains targeting two B-cell antigens, CD79a and CD19, inducing potent T-cell-mediated cytotoxicity while effectively limiting cytokine release. This dual-target strategy has potential ...
- Source: drugdu
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- September 2, 2026

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