Chinese-developed Respiratory Drug Acetylcysteine Oral Solution Approved by U.S. FDA on March 20

　　【Pharmaceutical Network Product InformationOn March 20, multiple new drugs were approved in the United States, including a China-produced treatment for respiratory diseases.
 

On March 20, Novartis, Johnson & Johnson, Zhejiang Conba Pharmaceutical Co., Ltd., and other companies announced that their products and combination therapies had been approved by the U.S. FDA for the treatment of kidney disease, gastric cancer, Crohn's disease, and respiratory conditions.
 

Yesterday, Novartis' oral medication Fabhalta® (iptacopan hydrochloride capsules, iptacopan) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult C3 glomerulopathy (C3G) to reduce proteinuria, becoming the first approved therapy for this disease.
 

Fabhalta has the potential to treat multiple indications. In December 2023, the U.S. FDA approved Fabhalta for marketing as the first oral monotherapy for treating paroxysmal nocturnal hemoglobinuria (PNH) in adults. Notably, on March 1 this year, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of the "first-in-class" oral complement alternative pathway factor B inhibitor Fabhalta for marketing to treat adult patients with C3 glomerulopathy (C3G).
 

Johnson & Johnson announced that the FDA has approved TREMFYA® (guselkumab) as the first IL-23 inhibitor to offer dual options of subcutaneous (SC) and intravenous (IV) induction therapy for the treatment of adult patients with moderately to severely active Crohn's disease.
 

Guselkumab is the world's first approved interleukin-23 (IL-23) inhibitor, which can selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 receptor, showing good efficacy for various autoimmune diseases. In China, in February this year, Johnson & Johnson's Guselkumab Injection (Intravenous Infusion) (Tremfya) and Guselkumab Injection (Tremfya) were approved for the treatment of adult patients with moderate to severe active Crohn's disease.
 

Merck announced that the development of the重磅 PD-1 inhibitor Keytruda (pembrolizumab), in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy, is used as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
 

Keytruda, a PD-1 inhibitor developed by Merck, enhances the ability of the human immune system to detect and destroy cancer cells. In 2024, the drug achieved sales of $29.482 billion with an 18% growth rate. Currently, Merck is further exploring the clinical potential of this drug through combination therapies, research on early-stage cancer applications, and the development of a subcutaneous injection formulation.
 

Conba's wholly-owned subsidiary Jinhua Conba's Abbreviated New Drug Application for Acetylcysteine Solution Approved in the U.S. Acetylcysteine, as a mucolytic agent, is used to treat respiratory diseases with excessive thick mucus secretion, such as acute bronchitis, chronic bronchitis and its exacerbations, emphysema, mucus plugging syndrome, and bronchiectasis.
 

Global sales of acetylcysteine preparations in 2023 were approximately US$1.603 billion, including about US$41 million from the sales of acetylcysteine solution in the U.S. market. To date, the company has invested RMB15.13 million in research and development expenses. Notably, prior to this, the Abbreviated New Drug Application (ANDA) for entecavir tablets submitted by the wholly-owned subsidiary, Conba USA, was approved by the U.S. Food and Drug Administration.
 

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