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Kangfang Biopharma’s new dual-antibody drug Ivoside is planned to be included in the breakthrough therapy designation for the treatment of triple-negative breast cancer

Shanghai Securities News China SecuritiesNet News (Reporter Zhang Xue) On October 24, Kangfang Bio ‘s Class 1 new drug PD-1/VEGF dual antibody Ivoside (AK112) injection was planned to be included in the breakthrough therapy variety. The indication is Ivosidemab combined with chemotherapy as the first-line treatment for locally advanced unresectable or metastatic triple-negative breast cancer. Ivoside is a new dual-antibody drug with a synergistic anti-tumor mechanism of “tumor immunity + anti-angiogenesis.” It simultaneously targets two important targets, PD-1 and VEGF, and synergistically exerts both tumor immunity and tumor anti-angiogenesis mechanisms, potentially providing a more effective treatment option for these patients. In February 2025, Kangfang Bio announced that the first patient had been enrolled in the multicenter, randomized, double-blind Phase 3 clinical study (HARMONi-BC1/AK112-308) of Ivoside combination therapy as the first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Source：https://finance.eastmoney.com/a/202510243543410637.html
- Source: drugdu
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- October 29, 2025
The KEX02 live bacteria capsule combined with PD-1 inhibitor for the treatment of non-small cell lung cancer is in Phase I clinical trials.

an investor asked on the investor interaction platform: Regarding the innovative　intestinal microecology drugs of the subsidiary Juntuo Biotechnology.What is the progress of the pipeline? What is the progress of the trial of combining PD-1 inhibitors for the treatment of non-small cell lung cancer? Ketuo BioOn October 24, 2019, the company (300858.SZ) announced on its investor engagement platform that it and Shenzhen Weizhijun Biotechnology Co., Ltd. are steadily advancing clinical research on their pipeline drug, KEX02 Live Bacteria Capsules, in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer. The project is currently in Phase I clinical trials. The company will disclose information promptly based on progress. Source：https://finance.eastmoney.com/a/202510243543555259.html
- Source: drugdu
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- October 29, 2025
Zoletinib, a new generation TRK inhibitor, debuts on the international stage

Shanghai Securities News China SecuritiesNet News (Reporter Zhang Xue) The reporter learned from InnoCare Pharma that at the 2025 International Society of Pediatric Oncology (SIOP) Annual Meeting held recently, Professor Zhang Yizhuo, Director of the Department of Pediatric Oncology at the Cancer Prevention and Treatment Center of Sun Yat-sen University (as the main researcher), and team member Professor Wang Juan (representing a multi-center researcher) orally reported the Phase I/II clinical data of China’s independently developed new generation pan-TRK inhibitor zolecletinib in children and adolescents with advanced solid tumors, which attracted the attention of the global academic community. Studies have shown that zolecatinib exhibits controllable safety and good anti-tumor activity in children/adolescents with NTRK gene fusion-positive solid tumors, indicating that it is a potential treatment for NTRK gene-driven malignant tumors, especially in overcoming the resistance of first-generation TRK inhibitors, showing good effectiveness, bringing new treatment directions for this type of tumor. The report notes ...
- Source: drugdu
- 85
- October 29, 2025
This is a common industry practice

　　Red Star Capital Bureau reported on October 15th that last night, Sinocell(688520.SH) disclosed a plan for a private placement, with the total amount of funds raised not exceeding 900 million yuan, which will be used entirely to supplement working capital. 　　On September 5th, the Shanghai Stock Exchange issued an inquiry regarding SinocellTech’s private placement, requesting clarification on issues such as the company’s increasing sales expenses, patient welfare and care programs, and external donations. Yesterday, SinocellTech released its response report. 　　Red Star Capital Bureau noticed that in recent years, Sinocell has expanded its product sales by providing subsidies to patients. On October 15, Sinocell SecuritiesThe Ministry responded to the Red Star Capital Bureau, saying that providing large subsidies to patients is a common practice in the industry and is beneficial for companies to promote their products. 　　Previously, Sinocell was embroiled in a controversy over medical insurance fraud. In response, Sinocell’s securities ...
- Source: drugdu
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- October 29, 2025
GlaxoSmithKline expands herpes zoster vaccine indications to children aged 18 and above

On October 14, a reporter from Interface News learned from GlaxoSmithKline that the China National Medical Products Administration has approved Shingrix (GlaxoSmithKline’s recombinant herpes zoster vaccine (CHO cells)) for the prevention of herpes zoster in adults aged 18 and above who have an increased risk of developing herpes zoster due to immunodeficiency or immunosuppression caused by known diseases or treatments (such as autologous hematopoietic stem cell transplantation). To date, Shingrix is the first and only vaccine approved by the China National Medical Products Administration for use in this population. This approval builds on the previous expansion of its indication for adults aged 50 and above. https://finance.eastmoney.com/a/202510143533562628.html
- Source: drugdu
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- October 29, 2025
【EXPERT Q&A】Why do Class II and Class III medical devices need to be registered?

Drugdu.com expert’s response: Class II and Class III medical devices require registration, primarily for the following reasons: I. Regulatory Requirements The Regulations on the Supervision and Administration of Medical Devices explicitly stipulate that Class II and Class III medical devices must undergo registration management. Medical devices that have not been registered are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, which enterprises must adhere to in order to ensure lawful business operations. II. Risk Control Class II medical devices carry moderate risks: Examples include thermometers, sphygmomanometers, and electrocardiographs. If there are issues with the product quality or safety, it may lead to misdiagnosis, mistreatment, or certain harm to the patient’s body. Class III medical devices pose higher risks: These include devices such as cardiac pacemakers, artificial joints, and implantable cardiac stents. These products are typically used to ...
- Source: drugdu
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- October 29, 2025
Huali Family-owned company Haihe Pharmaceuticals and Dapeng Pharmaceuticals have reached a licensing cooperation agreement

On October 16, the gorgeous familyShanghai Haihe Pharmaceutical Research and Development Co. , Ltd. (hereinafter referred to as “Haihe Pharmaceutical”), a joint venture of Huali Family Co., Ltd. (hereinafter referred to as “Huali Family”), and Taiho Pharmaceutical Co., Ltd. (hereinafter referred to as “Taiping Pharmaceutical”) have reached an exclusive licensing agreement in Japan for the independently developed PI3Kα inhibitor resolise (CYH33). This collaboration marks another in-depth collaboration between Haihe Pharmaceuticals and Dapeng Pharmaceuticals, following the development of Glumetinib. It focuses on the development, production, and commercialization of risolide in Japan. Under the agreement, Dapeng Pharmaceuticals will obtain exclusive rights to risolide in Japan, while Haihe Pharmaceuticals will receive an upfront payment, development and sales milestone payments, and royalties based on the drug’s sales in Japan. The cooperation on Resolisab is not accidental, but a renewed collaboration between Haihe Pharmaceuticals and Dapeng Pharmaceuticals based on trust. As early as last year, ...
- Source: drugdu
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- October 28, 2025
Antibiotic resistance poses a threat to global health

The World Health Organization recently released the “2025 Global Antibiotic Resistance Monitoring Report” and warned that the problem of resistance to commonly used antibiotics is widespread around the world, and the increasing resistance to basic antibiotics poses an increasingly serious threat to global health. The report predicts that one in six laboratory-confirmed bacterial infections causing common infections worldwide will be resistant to antibiotic treatment by 2023. Between 2018 and 2023, antibiotic resistance increased in more than 40% of monitored pathogen-antibiotic combinations, with an average annual increase of 5% to 15%. The report, which collected data from more than 100 countries, published for the first time the data on the use of drugs for the treatment of urinary tract and gastrointestinal infections, blood flu,The report provides estimates of resistance to 22 antibiotics for infections and gonorrhea. The report covers eight common bacterial pathogens, including Acinetobacter baumannii and Escherichia coli, each of ...
- Source: drugdu
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- October 28, 2025
Watson Biopharma’s 13-valent pneumococcal conjugate vaccine is now available in Malaysia

Recently, Yunnan Watson BioYuxi Watson Biotechnology Co. , Ltd., a subsidiary of Watson Biotechnology Co., Ltd. (hereinafter referred to as ” Watson Biotechnology ” ), and Pharmaniaga Lifescience Sdn. Bhd. (hereinafter referred to as “PLS”), a wholly-owned subsidiary of Pharmaniaga Berhad of Malaysia, have officially signed an agreement for the distribution and localized production of the 13-valent pneumococcal polysaccharide conjugate vaccine (hereinafter referred to as “13-valent pneumococcal conjugate vaccine” or “PCV-13”) in Malaysia. Under the agreement, PLS will serve as Watson Biotechnology’s partner in Malaysia, jointly promoting technology transfer, localized production, and commercialization of PCV-13. After in-depth business negotiations and technical exchanges, Watson Bio and PLS reached a consensus on core terms such as cooperation model and technology implementation path, and ultimately facilitated the signing of this cooperation agreement. PCV-13 effectively prevents invasive diseases caused by pneumococci, including pneumonia, meningitis, and bacteremia, providing critical protection for infants and children under six years old, particularly against ...
- Source: drugdu
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- October 28, 2025
Canagliflozin tablets obtain drug registration certificate

Southern Finance reported on October 27 that Huahai Pharmaceutical(600521) announced on October 27 that the company recently received the “Drug Registration Certificate” for canagliflozin tablets approved and issued by the State Food and Drug Administration. This product is used in combination with metformin hydrochloride: when blood sugar control is poor with metformin hydrochloride alone, it can be used in combination with metformin hydrochloride, combined with diet and exercise to improve blood sugar control in adult patients with type 2 diabetes; this product is used in combination with metformin hydrochloride and sulfonylurea drugs: when blood sugar control is poor with the combination of metformin hydrochloride and sulfonylurea drugs, it can be used in combination with metformin hydrochloride and sulfonylurea drugs, combined with diet and exercise to improve blood sugar control in adult patients with type 2 diabetes. Source：https://finance.eastmoney.com/a/202510273545770287.html
- Source: drugdu
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- October 28, 2025

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