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Clinical trial application for olopatadine-mometasone nasal spray approved by NMPA

On March 9th, Nanfang Finance News reported that Changfeng Pharmaceutical (02652.HK) issued a voluntary announcement stating that its Clinical Trial Application (CTA) for olopatadine-mometasone nasal spray has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China. This product is the first olopatadine-mometasone nasal spray in China to submit a generic drug clinical trial application. It is intended for the treatment of moderate to severe allergic rhinitis symptoms in adults and adolescents aged 12 and above. It is a combination antihistamine and corticosteroid formulation, designed to improve treatment convenience and patient compliance. This approval marks the product’s formal entry into the clinical trial stage and is an important validation of the company’s capabilities in complex nasal spray formulations and drug-device integration technology. It also complements the existing AR/CRS product portfolio (such as Shufeimin® and mometasone furoate nasal spray), covering a wider age range and disease ...
- Source: drugdu
- 57
- March 9, 2026
Superior to standard therapy! Johnson & Johnson’s blockbuster new drug combination therapy receives FDA approval

On March 5, Johnson & Johnson announced that the U.S. FDA has approved the combination therapy of teratumab and daratumumab (subcutaneous injection ) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior line of therapy (including proteasome inhibitors and immunomodulatory agents) . Johnson & Johnson’s press release stated that this combination therapy is expected to become a new standard of care for second-line treatment of MM.Teritumumab is the world’s first approved BCMA×CD3 bispecific antibody , previously approved for late- line treatment of multiple myeloma , with sales of $670 million in 2025 (+22.1%) . Daratumumab subcutaneous injection has previously been approved for the treatment of several different MM indications. In 2025 , global sales of daratumumab (intravenous + subcutaneous) reached $14.351 billion . This approval for the new indication is based on data from the ongoing Phase III MajesTEC-3 ...
- Source: drugdu
- 64
- March 9, 2026
For the first time, a domestically produced ultra-long-acting TSLP bispecific antibody has been approved for clinical trials.

On March 9, the CDE website showed that SKB575 (HBM7575) injection, jointly submitted by Kelun Biotech and Harbour BioMed , was approved for clinical trials for the treatment of atopic dermatitis . Public information shows that SKB575 is an ultra-long-acting bispecific antibody targeting thymic stromal lymphopoietin ( TSLP) , developed in collaboration between Kelun Biotech and Harbour BioMed , and has the best potential in its class globally . In addition, Kelun Biotech and Harbour BioMed have collaborated to develop a TSLP monoclonal antibody , SKB378 ( HBM9378) , which is currently undergoing a Phase II clinical trial for asthma. In January 2025, SKB378 was licensed to Windward Bio under a NewCo agreement with an upfront and milestone payments of $970 million. https://mp.weixin.qq.com/s/u1rDHGr8UnkPwwZ-w3R9SQ
- Source: drugdu
- 58
- March 9, 2026
With Hengrui entering the fray, can Mingrui hold its ground?

Recently , the Center for Drug Evaluation (CDE) announced that Chengdu Hengrui Pharmaceutical’s application for marketing approval of hippuric acid urotropine tablets has been officially accepted. This makes it the second company in China to submit an application for marketing approval of this product, following Hunan Mingrui Pharmaceutical, which means that this niche market is about to welcome a new competitor. Urotropin hippurate is a urinary tract medication primarily used for the prevention and treatment of chronic, recurrent urinary tract infections. This product exerts its antibacterial effect by slowly releasing formaldehyde in an acidic environment, making it particularly suitable for patients requiring long-term preventative medication. While urotropin hippurate tablets haven’t been among the most popular blockbuster drugs in recent years, this relatively low competition has created opportunities for newcomers. Especially in clinical settings, products focused on urinary tract infection prevention, although not necessarily large-scale, often have relatively stable demand. According ...
- Source: drugdu
- 60
- March 9, 2026
$230 million! Another BCI company completes Series C funding.

According to recent foreign media reports, Science Corporation announced that its oversubscribed $230 million Series C funding round has ended. According to Science Corporation, participants in this funding round include Lightspeed Venture Partners, Khosla Ventures, Y Combinator, IQT, and Quiet Capital. The funds will be used to accelerate the commercialization of its brain-computer interface technology. To date, the company has raised approximately $490 million in total funding . Science Corporation, founded in 2021 and headquartered in Alameda, California, is led by Neuralink co-founder Max Hordak and is currently advancing clinical trials of the Prima retinal implant . It’s worth mentioning that Science possesses the Prima retinal implantation technology developed by Pixium Vision. The Prima system, a photovoltaic alternative to photoreceptor cells, has received Breakthrough Device designation from the U.S. Food and Drug Administration , allowing for the simultaneous use of central prosthetic vision and peripheral natural vision. Furthermore, Prima technology ...
- Source: drugdu
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- March 9, 2026
【EXPERT Q&A】When conducting clinical trials with in vitro diagnostic reagents, do the supporting instruments need to obtain certificates

Drugdu.com expert’s response: Whether supporting instruments require prior certification when in vitro diagnostic (IVD) reagents undergo clinical trials necessitates a case-by-case analysis, as detailed below: I. Supporting Instruments Already Marketed and Certified If the supporting instrument is a product already on the market and has obtained relevant certifications (e.g., medical device registration certificate), it can be directly used in clinical trials. In this case, the following must be ensured: Complete Instrument Qualifications: Provide the instrument’s production license, quality management system certificate, product inspection report, and other documents to demonstrate compliance with regulatory requirements. Sufficient Performance Verification: Clearly specify the model, specifications, and compatibility with the reagent of the supporting instrument in the clinical trial protocol, and verify its detection performance (e.g., accuracy, precision) through pre-trials. Comprehensive Usage Records: Document the receipt, storage, distribution, usage, and maintenance of the instrument to ensure traceability throughout the trial process. II. Supporting Instruments as ...
- Source: drugdu
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- March 9, 2026
Anglikang Adenosylcobalamin Capsules Obtain Drug Registration Certificate

March 4th – AnglikangThe company announced that it recently obtained adenosine cobalt from the National Medical Products Administration.The company has obtained the Drug Registration Certificate for Amino Capsules. This drug is indicated for the adjunctive treatment of megaloblastic anemia, nutritional anemia, anemia of pregnancy, polyneuritis, radiculitis, trigeminal neuralgia, sciatica, nerve palsy, as well as nutritional disorders and radiation- and drug-induced leukopenia. The company received the notification of acceptance for its marketing authorization application in June 2024 and recently received approval from the National Medical Products Administration. The announcement indicates that, according to relevant national policies, obtaining the Drug Registration Certificate is considered equivalent to passing the consistency evaluation. This drug registration certificate will further enrich the company’s product pipeline; however, drug sales are easily affected by factors such as national policies and changes in the market environment, and there is considerable uncertainty regarding specific sales performance. https://finance.eastmoney.com/a/202603053663192752.html
- Source: drugdu
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- March 6, 2026
Two Minoxidil Topical Solution Applications from its Subsidiary Approved

China Securities Intelligent Finance – China Pharmaceutical(600056) announced on March 6 that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., recently received two “Approval Notices for Supplementary Applications” for minoxidil liniment issued by the National Medical Products Administration, becoming the marketing authorization holder for the drug. The announcement indicates that minoxidil topical solution is a dermatology and ENT medication used to treat male pattern baldness and alopecia areata. The National Medical Products Administration (NMPA) accepted a supplementary application for a change of marketing authorization holder for this drug in January 2026, and the project has accumulated an investment of approximately 6.45 million yuan as of the date of this announcement. According to the third-party database Menet, the drug’s sales in China’s three major terminals and six major markets reached approximately 447 million yuan in 2024, and approximately 315 million yuan in the first three quarters of 2025. The company stated that ...
- Source: drugdu
- 64
- March 6, 2026
Zhejiang Medicine’s ARX305 Initiates Phase II Clinical Trial

On the evening of March 5th that Zhejiang Medicine…(600216) issued an announcement stating that its subsidiary, Zhejiang Xinma Biopharmaceutical Co., Ltd. (hereinafter referred to as “Xinma Bio”), has initiated a single-arm, open-label phase II clinical study on the efficacy and safety of its injectable recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate (ARX305) for relapsed/refractory lymphoma. Zhejiang Medicine stated that the recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate for injection (ARX305) is a new generation monoclonal antibody-drug conjugate jointly developed by Newcode Biotech and Ambrx, Inc. of the United States, under a “Cooperative Development and Licensing Agreement” signed on October 22, 2019. It is used to treat advanced tumors expressing CD70 and belongs to innovative biotechnology drugs. https://finance.eastmoney.com/a/202603053663319462.html
- Source: drugdu
- 59
- March 6, 2026
Indacaterol Mometasone Inhalation Powder Clinical Trial Approved for Asthma Treatment

On March 5, CSPC Pharmaceutical Group (01093) announced that its indacaterol mometasone inhalation powder has been approved by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. This product is primarily used for maintenance treatment of asthma in adults and adolescents aged 12 and above, and has the effects of relaxing smooth muscles and dilating the bronchi. Indacaterol mometasone inhaler powder is the first once-daily ICS-LABA combination inhaler included in the National Medical Insurance Catalog (2022 Edition), providing asthma patients with a more efficient and convenient treatment option. https://finance.eastmoney.com/a/202603053663314598.html
- Source: drugdu
- 59
- March 6, 2026

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