media – Page 35 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Are the problems with OX40 more serious than we thought?

The OX40 monoclonal antibody has had a troubled history. On March 3, Kylin Pharmaceutical announced that due to the addition of a new case of Kaposi’s sarcoma in clinical trials, the company decided to discontinue all clinical studies of its OX40 monoclonal antibody Rocatinlimab. This breaking news has once again thrust the OX40 monoclonal antibody into the spotlight. Once, this was a promising new area of autoimmune medicine that industry giants had high hopes for. However, the results were less than satisfactory, forcing the market to re-evaluate the competitiveness of OX40 monoclonal antibody. However, with the exposure of the risk of tumorigenesis, OX40 monoclonal antibodies may face more challenges in the field of autoimmune diseases. 01 Cancer Controversy On March 3, a news release from Peking Union Medical College Hospital brought the OX40 monoclonal antibody into the spotlight. Hsieh Ho Kirin stated that a recent safety review of Rocatinlimab revealed ...
- Source: drugdu
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- March 10, 2026
Up to $690 Million! GSK Sells Liver Disease Drug

On March 9, 2026, GSK and Alfasigma S.p.A. announced a licensing agreement, under which Alfasigma will obtain global exclusive rights to linerixibat for the development, manufacture and commercialization of the drug. According to reports, linerixibat is an investigational ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC). Linerixibat has been granted Orphan Drug Designation in the United States, the European Union and Japan, as well as Priority Review in China for the treatment of cholestatic pruritus in PBC patients. Based on positive data from the Phase III GLISTEN trial, marketing applications for linerixibat are currently under regulatory review in the United States, the European Union, the United Kingdom, China and Canada. The GLISTEN trial met its primary endpoint and key secondary endpoints, demonstrating rapid, significant and sustained improvements in cholestatic pruritus and pruritus-related sleep disturbance compared with placebo. ...
- Source: drugdu
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- March 10, 2026
PharmaLab Japan

Organiser：Reed Exhibitions Time：May 20 – 22, 2026 Address：3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: General Exhibition Area: Products related to cell biology, drug research, various equipment, consumables, reagents, products related to biological omics, biological imaging equipment, software, databases, biological resources, biological materials, biological industry clusters, investment, industrial upgrading, etc. Regenerative Medicine Research Exhibition Area: Cell culture, cell production products/services, regenerative medicine, cellular medicine, etc. Contract Services Exhibition Area: Contract research and development, testing, analysis, contract expression, synthesis, refinement, clinical research CMO, CRO, SMO, technology transfer TLO, IP consulting, etc. Precision Processing Exhibition Area: Precision/fine processing technologies, microfluidics (microTAS, Bio MEMS, biochips, biosensors), microchannels, microsystems, etc. About PharmaLab Japan： PharmaLab Japan is one of Asia’s leading pharmaceutical laboratory exhibitions. The highly anticipated 250 conference/seminar events will provide attendees with the best venue to learn about life sciences knowledge. As a comprehensive biotechnology ...
- Source: drugdu
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- March 10, 2026
Marketing application for HSK39297 tablets, an innovative drug for paroxysmal nocturnal hemoglobinuria, has been accepted

Harsco Pharmaceutical(002653) announced on the evening of March 8 that its subsidiary, Sichuan Haisco Pharmaceutical Co., Ltd., recently received an Acceptance Notice from the National Medical Products Administration (NMPA) for its independently developed HSK39297 tablets for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This drug is classified as a Class 1 chemical drug under China’s new chemical drug registration classification and is a leading domestic CFB inhibitor targeting PNH. According to the announcement, HSK39297 is a highly potent and selective small molecule inhibitor of complement factor B. It inhibits FB activity, blocking the activation of the alternative pathway and complement amplification circulation, thereby suppressing the activity of the entire complement pathway. It is designed to treat various diseases mediated by abnormal complement activation. In PNH patients, this drug acts at the proximal end of the complement cascade alternative pathway, simultaneously controlling C3b-mediated extravascular hemolysis and terminal complement-mediated ...
- Source: drugdu
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- March 9, 2026
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
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- 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
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- 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
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- 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
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- 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

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