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GSK’s application for marketing approval in China for its recombinant herpes zoster vaccine pre-filled syringe formulation has been accepted.

recently announced that the National Medical Products Administration (NMPA) of China has formally accepted its marketing application for Shingrix (recombinant herpes zoster vaccine [CHO cell], abbreviated as RZV) pre-filled syringe (PFS) formulation, which is used to prevent shingles. The active ingredient in the pre-filled syringe formulation is completely identical to that of the existing lyophilized formulation (lyophilized antigen + liquid adjuvant), simplifying the vaccination preparation process for medical personnel by eliminating the need for reconstitution of the lyophilized antigen before use. A GSK press release stated that during the 9th China International Import Expo, it showcased the latest progress in the deployment of its innovative vaccines and drugs in China, with Shingrix, the shingles vaccine that continues to expand its beneficiary population, being one of the highlights of its booth. Following approval for expanded indications in China, Shingrix has achieved new progress in dosage form innovation. GSK’s pre-filled syringe formulation ...
- Source: drugdu
- 38
- November 13, 2026
Novo Nordisk has submitted an application for marketing approval in China for its once-weekly subcutaneous injection of CagriSema, for long-term weight management.

On November 10, the CDE website showed that Novo Nordisk’s (Novo Nordisk) marketing application for the Class 1 new drug, camrelintide smegglutide injection, for long-term weight management, was accepted. CagriSema is an investigational fixed-dose combination therapy consisting of the long-acting amylintide receptor agonist and the GLP-1 receptor agonist semagglutide, administered subcutaneously once weekly. The two components work synergistically through different and complementary mechanisms of action on pathways related to appetite and weight regulation. In December 2025, Novo Nordisk submitted a New Drug Application to the FDA for CagriSema, which is designed to help obese or overweight adult patients lose weight and maintain the weight loss effect in the long term, especially for patients with at least one weight-related comorbidity, in conjunction with a low-calorie diet and increased physical activity. Novo Nordisk stated that, if approved, CagriSema will be the first injectable combination of a GLP-1 receptor agonist and an amylin ...
- Source: drugdu
- 38
- November 13, 2026
Colombia’s INVIMA approves Sinotherapeutics’ generic posaconazole delayed-release tablets

On the evening of November 12, Sinotherapeutics (688247) said Colombia’s National Food and Drug Surveillance Institute (INVIMA) had approved its generic application for posaconazole delayed-release tablets. Posaconazole is a triazole antifungal that inhibits ergosterol synthesis and is used for invasive Aspergillus or Candida infections. The filing said the product had previously received first-generic approvals in the US and China, as well as approvals in Australia, Singapore, Saudi Arabia, Israel, Canada and several EU countries. It also received a special import permit in Vietnam. The Colombian approval allows the company to sell the product there. Sales will depend on local regulation, market conditions and distribution development. Source: http://finance.eastmoney.com/a/202611123929744731.html
- Source: drugdu
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- November 13, 2026
Sansure Biotech receives China registration for a liver cancer diagnostic kit

Sansure Biotech (688289.SH) reported that China’s National Medical Products Administration had issued a medical device registration certificate for its human OTX1, MTHFD2 and FAR1 gene methylation assay. The fluorescence probe PCR kit qualitatively detects methylation of these genes in peripheral blood plasma to aid diagnosis in people at high risk of primary hepatocellular carcinoma. Source: http://finance.eastmoney.com/a/202611123929773912.html
- Source: drugdu
- 34
- November 13, 2026
Baheal renames itself as it expands into drug development and manufacturing

Qingdao Baheal Medical announced on November 11 that it had completed the corporate registration for its renaming as Baheal Pharmaceutical Group. Its Chinese stock short name changed on November 12, and its stock code remains 301015. Baheal acquired Shanghai Baheal Pharmaceutical in 2024, extending its business from commercialization into drug development and manufacturing. The company said its manufacturing operations would support its international expansion. Source: http://finance.eastmoney.com/a/202611123929870533.html
- Source: drugdu
- 36
- November 13, 2026
Everest Medicines receives China approval for 100 mg eravacycline injection

On November 13, Everest Medicines (01952) announced that China’s drug regulator had approved a new 100 mg strength of its eravacycline hydrochloride for injection. The 50 mg strength was approved in China in 2023 for complicated intra-abdominal infections in adults. The company expects the new strength to give clinicians more preparation options and reduce handling and waste. Eravacycline is a fully synthetic broad-spectrum fluorocycline antibiotic. Everest has obtained a manufacturing license for its Jiashan site and is moving ahead with local production in China. Source: http://finance.eastmoney.com/a/202611133930417557.html
- Source: drugdu
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- November 13, 2026
China approves Xinnova’s imipenem–cilastatin–funobactam for bacterial pneumonia

On November 12, Xinnova reported that China’s National Medical Products Administration had approved its in-house Class 1 drug imipenem–cilastatin–funobactam for injection for hospital-acquired and ventilator-associated bacterial pneumonia. It is the company’s first marketing approval since its September 16 STAR Market listing. The product combines imipenem and cilastatin sodium with the novel beta-lactamase inhibitor funobactam. Results from the multinational Phase III trial appeared in The Lancet Infectious Diseases on November 4. Imipenem–cilastatin–funobactam was noninferior to imipenem–cilastatin–relebactam for day-14 all-cause mortality. Funobactam inhibits several beta-lactamases, including class D enzymes commonly found in Acinetobacter baumannii. The filing cited carbapenem resistance of approximately 60% to 70% in A. baumannii from relevant cases in large Chinese general hospitals. China accepted the marketing application in July 2025. In the US, the product has received Fast Track and Qualified Infectious Disease Product designations. The company has built a sterile powder facility with annual capacity of three million ...
- Source: drugdu
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- November 13, 2026
Hybio’s Pingshan site completes FDA combination product inspection with NAI classification

Hybio Pharmaceutical (300199) said its Pingshan site completed a joint US FDA inspection of drug-device combination products with a No Action Indicated (NAI) classification. It was the site’s third successful FDA inspection. The inspection covered drug cGMP and device quality systems, including manufacturing and assembly validation, design and development, risk management, traceability and data integrity. The company said its Longhua R&D laboratory, Wuhan peptide API site and Pingshan finished dosage site had all received NAI outcomes. Hybio also reported that HY3003 injection received US clearance for its first clinical trial, while China accepted a clinical trial application for HY3003 tablets. The oral candidate is a GLP-1R, GIPR and GCGR triple agonist under development for indications including weight management, type 2 diabetes and metabolic dysfunction-associated steatohepatitis. R&D expenses rose 117.11% year on year to RMB 161 million in the first nine months of 2026, equivalent to 12.95% of revenue. Third-quarter revenue ...
- Source: drugdu
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- November 13, 2026
enGene to Initiate BLA Submission by Year End and Reports New LEGEND Data in Bladder Cancer

On November 11, clinical-stage non-viral genetic medicines company enGene (Nasdaq: ENGN) announced updated results from the pivotal Cohort 1 of its Phase 2 LEGEND trial of detalimogene voraplasmid, which are expected to form the basis for a Biologics License Application (BLA) with the U.S. FDA. The cohort enrolled 125 patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. As the data matured, the primary endpoint of complete response at any time improved to 56% from 54%, while the key secondary endpoint of the Kaplan-Meier estimate of duration of response of at least 12 months improved to 43% from 25%, and median duration of response improved to 10.1 months from 8.6 months. On safety, only 2% of patients experienced a serious treatment-related adverse event, with no Grade 4 or Grade 5 events reported. Following a pre-BLA meeting, the company aligned with the FDA on the efficacy-evaluable population ...
- Source: drugdu
- 60
- November 12, 2026
CorMedix to Acquire Heron Therapeutics’ Commercial Assets for $145 Million in Cash and Stock

On November 11, CorMedix announced a definitive agreement to acquire substantially all assets of Heron Therapeutics, including a portfolio of four commercial-stage products. The transaction is expected to be immediately accretive to earnings and free cash flow and significantly diversify the company’s revenue base within hospital and acute care settings. The acquired portfolio includes four FDA-approved products—ZYNRELEF, APONVIE, CINVANTI and SUSTOL—which collectively generated approximately $150 million in trailing 12-month net revenue. The upfront consideration consists of $145 million in cash and approximately 14.6 million shares of CorMedix common stock. Heron is also eligible for up to $55 million in earn-out payments tied to 2028 net sales of ZYNRELEF. CorMedix anticipates $45 million to $60 million in annualized operating cost synergies by the end of 2027 through its existing commercial infrastructure. The acquisition is expected to close in the first quarter of 2027, subject to Heron stockholder approval and other customary ...
- Source: drugdu
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- November 12, 2026

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