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Mabwell Biopharma licenses two denosumab injections to Philippine pharmaceutical company UNILAB

On July 14, Mabwell Biopharma announced that the company’s two denosumab injections 9MW0311 (Prolia® biosimilar, domestic trade name: Mylishu®) and 9MW0321 (Xgeva® biosimilar, domestic trade name: Mabwell®) signed a licensing and commercialization agreement with the Philippine pharmaceutical company UNILAB, INC. (hereinafter referred to as “UNILAB”). According to the agreement, UNILAB will be responsible for the registration and sales of the two products in the Philippines, and Mabwell Biopharma will be responsible for the development, production and commercial supply of the products. It is reported that UNILAB is a leading pharmaceutical company in the Philippines, committed to the sales and promotion of high-quality new drugs in the Philippine market. According to IQVIA data, UNILAB ranks first in the pharmaceutical industry of the Association of Southeast Asian Nations with its production, registration and marketing capabilities. In August 2023, Mabwell Biopharma and UNILAB reached a strategic cooperation on adalimumab biosimilars, and the relevant ...
- Source: drugdu
- 242
- July 16, 2025
An IIT study based on an engineered extracellular vesicle mRNA platform to deliver full-length dystrophin for the treatment of Duchenne muscular dystrophy (DMD) has been initiated, opening a new paradigm for gene therapy

Researchers from Shenzhen Bay Laboratory, Shenzhen Academy of Medical Sciences, Peking University Shenzhen Graduate School, and Shanghai Spinoin Biotechnology Co., Ltd. recently collaborated with Shanghai Children’s Medical Center affiliated to Shanghai Jiao Tong University School of Medicine and obtained approval to conduct the world’s first clinical trial using a non-viral vector full-length dystrophin (FL-dystrophin) gene therapy to treat Duchenne muscular dystrophy (DMD) . This is also the first international clinical trial initiated by researchers (IIT) to introduce gene therapy drugs into humans using an extracellular vesicle delivery platform. The project, titled ” A novel mRNA platform based on engineered extracellular vesicles (EVs) to treat Duchenne muscular dystrophy “, aims to deliver FL-dystrophin mRNA through engineered extracellular vesicles, evaluate its safety, tolerability and preliminary efficacy in DMD patients, and provide patients with safer and more efficient gene therapy options. 01 Research background and scientific basis Duchenne muscular dystrophy is a fatal ...
- Source: drugdu
- 333
- July 16, 2025
Sinovent’s new drug application for marketing approval has been accepted, the nemesis of drug-resistant bacteria is here

On July 9, the CDE official website showed that Sinovent’s application for the marketing approval of imipenem-cilastatin sodium fonobactam for injection (hereinafter referred to as imipenem-cilastatin sodium fonobactam for injection) was officially accepted. This world-first new antibacterial drug is intended to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), directly addressing the most difficult problem of drug-resistant bacterial infection in clinical practice. Compared with other new β-lactamase inhibitors (such as avibactam, relebactam, etc.), this product has a wider and stronger inhibitory activity, and can comprehensively and effectively inhibit the common A, C, and D enzyme activities of Gram-negative bacteria. Behind this breakthrough is a key breakthrough in the field of drug-resistant bacteria by a Chinese pharmaceutical company that was established only 8 years ago. In the intensive care unit, hospital-acquired pneumonia and ventilator-associated pneumonia are common life-threatening infections. What is more worrying is that the detection rate of carbapenem-resistant ...
- Source: drugdu
- 217
- July 16, 2025
【EXPERT Q&A】How many types of EU CE certification are there?

Drugdu.com expert’s response: The EU CE certification is primarily classified into three types based on certification modes (COC, AOC, DOC) and multiple types based on product directives, while the certification path also involves different module combinations. Here is a detailed classification and explanation: I. Three Types Based on Certification Modes COC (Certificate of Compliance) Issuing Authority: Third-party organizations (e.g., intermediaries or testing and certification bodies). Content: Typically accompanied by technical documentation (TCF) such as test reports, and enterprises are also required to sign a Declaration of Conformity. Applicable Scenarios: Applicable to a variety of situations, whether for AOC or other products requiring certification under specific modes (e.g., B+D, B+E, H, etc.), a COC certificate may ultimately be obtained. AOC (EC Attestation of Conformity) Issuing Authority: EU Notified Bodies (NB). Content: According to EU regulations, only NB organizations are qualified to issue such certificates. Applicable Scenarios: Typically arises when product certification ...
- Source: drugdu
- 265
- July 16, 2025
Lepu Medical’s Sodium Hyaluronate Solution for Injection is Approved for Registration to Expand Business in the Consumer Healthcare Field

On the evening of July 11, Lepu MedicalDisclosure of a suggestive announcement regarding the registration approval of sodium hyaluronate solution for injection by NMPA. The company learned today that the sodium hyaluronate solution for injection independently developed by its subsidiary Sichuan Xingtai Pule Medical Technology Co., Ltd. has been approved for registration by the National Medical Products Administration (NMPA), with the registration certificate number of National Medical Device Registration No. 20253131324. The product is used in medical institutions for injection into the superficial dermis of the face to temporarily improve dry skin and dull complexion in adults. The announcement pointed out that the sodium hyaluronate solution for injection is a water light injection product. By accurately injecting nutrients into the superficial or middle layers of the dermis, it effectively solves the problem of skin care products being difficult to absorb through the skin. The successful approval of the sodium hyaluronate ...
- Source: drugdu
- 259
- July 15, 2025
Digene Pharmaceuticals’ Suvotinib Tablets are included in the latest version of the NCCN guidelines to create a new paradigm for the internationalization of China’s “original” new drugs

July 12, Digene (Jiangsu) Pharmaceutical Co., Ltd. (hereinafter referred to as “Digene Pharmaceutical”) held a press conference in Beijing on the approval of Shuvozal® in the United States. Reporters learned that ZEGFROVY® (generic name: Suvotinib tablets) of Digene Pharmaceuticals has been included in the National Comprehensive Cancer Network (NCCN) non-small cell lung cancer guidelines for the treatment of previously treated epidermal growth factor receptor (EGFR) exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC). ZEGFROVY® has become the only EGFR exon20ins NSCLC small molecule targeted drug in the world that has been included in the international authoritative lung cancer guidelines. Earlier, Shuwozhe® was approved for marketing by the U.S. Food and Drug Administration (FDA) through priority review on July 3, becoming the world’s first and only EGFRexon20ins NSCLC innovative drug approved in the United States.It is also China’s first independently developed global innovative . Professor Wang Mengzhao of Peking ...
- Source: drugdu
- 184
- July 15, 2025
Ascentage Pharmaceuticals is out with its powerful weapon

On July 10, according to the official website of NMPA, Ascentage Pharma’s highly anticipated pipeline product, lisatoclase tablets (APG-2575), has been conditionally approved for marketing for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously received at least one systemic treatment including a Bruton’s tyrosine kinase (BTK) inhibitor. You should know that before this, there was only one Bcl-2 inhibitor in the world – venetoclax. Since then, the research and development boom of Bcl-2 drugs can be said to have lasted for ten years. Now, it has finally borne fruit in the biotech company Ascentage Pharmaceuticals. A major target for crossing the cycle Bcl-2 is the founding member of the Bcl-2 regulatory protein family, the most notable feature of which is its regulatory role in mitochondrial apoptosis. The Bcl-2 family of proteins consists of members that promote or inhibit apoptosis, and controls apoptosis by controlling mitochondrial outer membrane ...
- Source: drugdu
- 236
- July 15, 2025
$10 billion! Merck bets on respiratory drugs

On July 9, Merck announced that it had reached a final agreement with Verona Pharma (VRNA), a biopharmaceutical company focusing on respiratory diseases. According to the agreement, Merck will acquire Verona’s American Depositary Shares (ADS) through a subsidiary at a price of US$107 per share, with a total transaction value of approximately US$10 billion. Through this acquisition, Merck will acquire Ohtuvayre, a first-in-class new COPD drug, expanding its R&D pipeline and product portfolio for the treatment of cardiopulmonary diseases, which is expected to drive growth over the next decade. This is not the first time Merck has made a big investment. According to public data, the patent for PD-1 inhibitor Keytruda, which accounts for nearly half of Merck’s revenue, is about to expire, and the US government is expected to negotiate for Keytruda under the IRA in 2026. Another best-selling drug of Merck, HPV vaccine Gardasil, is facing severe challenges ...
- Source: drugdu
- 295
- July 15, 2025
Expected to increase performance by over 40% in the first half of the year, with employee stock ownership being the first to promote high-quality development

On July 13th, Chengyi Pharmaceutical (603811) released a performance forecast announcement for the first half of the year. In the first half of 2025, the company expects to achieve a net profit attributable to the parent company of 107 million to 119 million yuan, a year-on-year increase of 40% to 55%; It is expected to achieve a non recurring net profit of 106 million to 113 million yuan, a year-on-year increase of 47.4% to 57.4%. The main reasons for the expected increase in performance are stated in the announcement, on the one hand, the continuous growth of the company’s joint drug sales, and on the other hand, the reduction of losses by the subsidiary in the previous year. The joint drug glucosamine hydrochloride capsules (hereinafter referred to as “glucosamine”) are the company’s main products and one of the main driving forces for performance growth in the first half of the ...
- Source: drugdu
- 169
- July 15, 2025
Kanghua Biotechnology plans to change ownership! Before the suspension, there was a significant increase in trading volume and a three-year consecutive decline in net profit. Shareholders are reducing their holdings and leaving the market

On the evening of July 13th, Kanghua Biotechnology (300841) announced that its controlling shareholder and actual controller, Wang Zhentao, is planning to change the company’s control rights, which may lead to a change in the company’s controlling shareholder and actual controller. Upon application to the Shenzhen Stock Exchange, the company’s stock will be suspended from trading starting from Monday, July 14th, with an expected suspension period of no more than 2 trading days. It should be noted that before the suspension, Kanghua Biotechnology saw a significant increase in trading volume on July 11th, with the latest stock price reaching 72.01 yuan per share. According to the data, Kanghua Biotechnology is mainly engaged in the research and development, production, and sales of human vaccines. The company has obtained drug registration certificates for vaccines such as freeze-dried human rabies vaccine (human diploid cell) and ACYW135 meningococcal polysaccharide vaccine. Kanghua Biotechnology’s net profit ...
- Source: drugdu
- 195
- July 15, 2025

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