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Despite positive news, the stock price fell after Watson Bio’s bivalent HPV vaccine received marketing authorization in Tanzania.

On July 23, an announcement from Watson Bio ( 300142.SZ ) attracted market attention. The bivalent HPV vaccine WALRINVAX (vial specification) produced by the subsidiary Yuxi Zerun has obtained a drug registration certificate issued by the Tanzania Medicines and Medical Devices Authority and is approved for marketing in the local market. This is not a simple news story about “going global”. Watson Bio’s Tanzanian registration certificate is both an “entry ticket” to the African market and a “must-answer question” regarding its commercialization capabilities. The positive announcement contradicted the stock price movement. On July 23, Watson Bio closed at 13.26 yuan, down 1.70%. image.png On July 24, the decline further widened, hitting a low of 12.72 yuan during the session. By the morning close, the stock was trading at 12.83 yuan, a drop of 3.24%. Other data showed that the stock price once fell to 12.75 yuan, a drop of as ...
- Source: drugdu
- 97
- July 27, 2026
Gan & Lee Pharmaceuticals’ Aspart Insulin 30 Injection Approved in India, Breaking Long-Term Monopoly of Original Drug Manufacturers

Recently, Gan & Lee Pharmaceuticals (stock code: 603087.SH) announced that its Aspart Insulin 30 Injection has officially obtained import marketing authorization from the Central Drugs Standard Control Organisation (CDSCO) of India, becoming the first approved biosimilar of Aspart Insulin 30 Injection in India. Breaking the monopoly of original research drugs and solving the problem of accessibility to diabetes diagnosis and treatment in India. India has one of the largest diabetes populations in the world. According to the latest data from the International Diabetes Federation (IDF), there are approximately 89.83 million people aged 20-79 with diabetes in India, a number projected to rise to 157 million by 2050, representing a growth rate of 75% .<sup> 1 </sup> With the continued growth of the local diabetes population, the market demand for high-quality, readily available insulin products is increasingly urgent. However, the supply of aspart insulin 30 injection in India has long relied ...
- Source: drugdu
- 91
- July 27, 2026
Paliperidone Palmate Injection from CSPC Pharmaceutical Group Approved for Marketing

On July 24, CSPC Pharmaceutical Group (1093.HK) announced that its independently developed second-generation antipsychotic long-acting injection, paliperidone palmitate injection (specifications include: (1) 0.75ml:75mg; (2) 1.0ml:100mg; (3) 1.5ml:150mg (calculated as C 23 H 27 FN 4 O 3 ) (hereinafter referred to as “the product”), has been approved for marketing by the National Medical Products Administration of the People’s Republic of China and is suitable for the treatment of acute and maintenance phases of schizophrenia. Compared to traditional antipsychotic drugs, this product only needs to be administered once a month, and it takes effect quickly after administration, requiring no oral medication supplementation. It can be used to treat patients in the acute phase. At the same time, monthly administration significantly improves patient medication adherence, avoids missed doses, and effectively reduces the relapse rate and readmission rate. This product is listed as a recommended medication in authoritative domestic and international treatment guidelines ...
- Source: drugdu
- 85
- July 27, 2026
FDA approves first ophthalmic bevacizumab for market.

On July 24, Outlook Therapeutics announced that ONS-5010 (bevacizumab, brand name: Lytenava) received FDA approval for the treatment of wet age-related macular degeneration (wAMD). This is the first ophthalmic bevacizumab formulation approved by the FDA. The original bevacizumab ( Avastin ) is an anti-VEGF-A monoclonal antibody developed by Roche and is currently only indicated for cancer patients. ONS-5010 has completed four Phase III studies to date, including NORSE ONE, NORSE TWO, NORSE THREE, and NORSE EIGHT . NORSE ONE was a proof-of-concept study that included 61 patients with wAMD. The results showed that the proportion of patients in the ONS-5010 group who achieved an increase of more than 15 letters in their best corrected visual acuity (BCVA) score was not significantly different from that in the ranibizumab group (11.8% vs. 22%).The NORSE TWO study included 228 patients with wAMD. Results showed that the proportion of patients achieving an increase of ...
- Source: drugdu
- 80
- July 27, 2026
【EXPERT Q&A】There are many export documents for medical devices. Which information should be placed on the product page in advance?

Drugdu.com expert’s response: When communicating with medical device suppliers, we often encounter a common situation: Enterprises hold CE certification, ISO certificates and can provide relevant supporting documents, but the content displayed on their product pages is overly simplistic. Some pages only include the product name, a few images, plus a few generic lines: “High quality”、“CE available”、“OEM supported” For suppliers, these messages are enough to highlight their product advantages. However, for overseas buyers, after seeing such content, they still cannot judge clearly: Whether this product meets their procurement requirements Whether the supplier has relevant experience in their target market Whether the supplier can cooperate to provide necessary documents for subsequent registration, customs clearance or local sales Medical device procurement differs greatly from ordinary commodity procurement. Before contacting suppliers, buyers usually learn about the enterprise’s capabilities and product details through the product page first. Therefore, it is unnecessary to upload all export-related ...
- Source: drugdu
- 97
- July 27, 2026
【EXPERT Q&A】When a buyer asks, “Can it be imported into our country?”, how should the supplier respond?

Drugdu.com expert’s response: In medical device foreign trade communication, many buyers do not ask for prices right away. Instead, they frequently raise questions like: “Can this product be imported into our country?” or “Do you have documents for our market?” Quite a few suppliers simply reply: “Yes, we can export.” This statement is not incorrect, but it fails to provide sufficient information for buyers. When a buyer asks “whether the product can be imported”, they do not merely want to confirm if the supplier has export experience. What they care more about are potential issues the product may encounter when entering the local market, including registration, certification, customs clearance, labeling, instructions for use, after-sales services and other related aspects. If a supplier only replies “we can export”, the buyer will have to ask numerous follow-up questions. Once the communication process becomes overly lengthy, the buyer is very likely to turn to other suppliers ...
- Source: drugdu
- 103
- July 24, 2026
Inner Mongolia Pharmaceutical Fair & Inner Mongolia Medical Device Exhibition

Organiser：Weilian Exhibitions Time：August 8th – 9th, 2026 Address：East End of East University Street, Hohhot, Inner Mongolia Autonomous Region Exhibition hall： Inner Mongolia International Convention and Exhibition Center Product range: Pharmaceuticals, health supplements, medical supplies, medical devices, adult products, beauty and personal care products, home medical rehabilitation products, epidemic prevention materials, maternal and infant products, equipment and packaging About Inner Mongolia Pharmaceutical Fair： Inner Mongolia Pharmaceutical Fair & Inner Mongolia Medical Device Exhibition (referred to as “Inner Mongolia Pharmaceutical Fair”) is a well-known domestic trade fair for pharmaceuticals and health products. Founded in 1999, it is known as the “barometer of the national pharmaceutical and health product industry”, “China’s No.1 fixed-city pharmaceutical exhibition”, and has ranked as the largest fixed-city exhibition in China for ten consecutive years. As one of the oldest and largest branded industry events in China’s pharmaceutical sector, it covers all links of medical R&D, production, operation ...
- Source: drugdu
- 115
- July 23, 2026
【EXPERT Q&A】What are the core requirements for manufacturers’ QMS under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR, the quality management system requirements for manufacturers are not limited to “production process compliance.” Manufacturers are expected to establish a quality management system that covers the full lifecycle of medical devices. In simple terms, the QMS should demonstrate that the product remains under continuous control from design and development, production and release, through to post-market feedback and risk control. The key requirements can be summarized in five areas: 1. Establish a quality management system that meets MDR requirements Manufacturers need to establish, implement, maintain and continuously improve their QMS. The system should cover processes such as product design and development, production, inspection, release, supplier management, document control, change control, nonconforming product handling, CAPA, internal audits and management review. 2. Include regulatory compliance in the QMS The QMS should clearly define product classification, conformity assessment routes, applicable standards, evidence of compliance with the General ...
- Source: drugdu
- 114
- July 22, 2026
INDO HEALTH CARE (Jakarta Medical Device Exhibition, Indonesia)

Organiser：KRISTA EXHIBITIONS Time： August 5th – 7th, 2026 Address：Jl. Gatot Subroto No.1, RT.1/RW.3, Gelora, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270, Indonesia Exhibition hall：Balai Sidang Jakarta Convention Center Product range: Medical Devices: Diagnostic medical equipment, traditional Oriental medicine therapies & equipment, dental instruments, clinic examination apparatus, obesity treatment and healthcare equipment, ophthalmic medical instruments Rehabilitation Equipment: Surgical instruments & equipment, therapeutic apparatus & equipment, radiological medical equipment, hospital facilities and emergency equipment, central supply equipment, Asian medicine & related devices, rehabilitation healthcare supplies, disposable instruments, other medical-related products Medical Supplies: Ward nursing equipment and appliances (beds, trolleys, tables, cabinets, racks, etc.); Disinfection products (medical air sterilizers, vacuum sterilizers, ultrasonic cleaning systems, disinfectants, etc.); Auxiliary products (oxygen generators, ventilators, sphygmomanometers, blood glucose meters, thermometers, potential therapy devices, radiation protection supplies, oxygen generation & supply equipment, blood bank facilities, medical data & image processing equipment, rehabilitation devices, special ...
- Source: drugdu
- 144
- July 21, 2026
【EXPERT Q&A】How are medical devices classified and managed?

Drugdu.com expert’s response: Medical devices are classified and managed into three categories ‌in ascending order of risk level‌, with the Rules for the Classification of Medical Devices as the core basis. 1. Management Classification of Three Categories of Medical Devices ‌Class I‌: Medical devices with low risk, whose safety and effectiveness can be ensured through routine management, such as ordinary medical surgical masks and medical examination gloves. ‌Class II‌: Medical devices with moderate risk that require strict control and management to ensure safety and effectiveness, such as clinical thermometers and non-invasive monitors. ‌Class III‌: Medical devices with relatively high risk that need particularly strict control measures to ensure safety and effectiveness, such as implantable cardiac pacemakers and artificial joints. 2. Supporting Classification Management Rules In addition to the risk classification of the products themselves, China also implements classified and hierarchical supervision for the production and operation links, clarifying the responsibilities of regulatory ...
- Source: drugdu
- 94
- July 20, 2026

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