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With a transaction volume exceeding $37.3 billion, psychotropic drugs have reached a “new level.”

In the global pharmaceutical landscape, the development of drugs for schizophrenia presents a paradoxical scene: it is both a “valley of death” where giants stumble and a frontier where capital pours in. In recent years, with breakthroughs in drugs with novel mechanisms of action, the sector has seen transaction volumes exceed $37.3 billion , propelling schizophrenia drugs to new heights! 01 Development and Competitive Landscape of Psychosomatic Drugs The schizophrenia market is a crucial component of the CNS (Chemical, Neuro, and Social Sciences) field, but its research and clinical translation face severe challenges. The success rate of new drugs in this area obtaining FDA approval is only about 6%, making it a veritable “valley of death” in pharmaceutical R&D. According to Expert Market Research, the antipsychotic drug market is projected to reach nearly $20 billion in 2024. This market size reflects the concentrated demand for medication from a long-term patient ...
- Source: drugdu
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- January 5, 2026
Sacituzumab Tirumotecan (TROP2 ADC) in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Locally Advanced or Metastatic NSCLC Granted Breakthrough Therapy Designation by NMPA

People’s Fortune News, Jan 5 — Sichuan Kelun Pharmaceutical (002422.SZ) announced on the morning of January 5 that its holding subsidiary, Kelun-Biotech, has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its TROP2-targeted antibody-drug conjugate (ADC), Sacituzumab Tirumotecan (sac-TMT, also known as SKB264/MK-2870; brand name: Jiatailai®). The designation applies to the combination of sac-TMT and MSD’s anti-PD-1 monoclonal antibody, Pembrolizumab (Keytruda®), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a PD-L1 tumor proportion score (TPS) ≥1% and are negative for EGFR mutations and ALK rearrangements. Additionally, Kelun-Biotech’s self-developed integrin β6 (ITGB6)-targeted ADC, SKB105 (also known as CR-003), has received Investigational New Drug (IND) approval from the CDE for clinical trials in the treatment of advanced solid tumors. https://finance.eastmoney.com/a/202601053608098625.html
- Source: drugdu
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- January 5, 2026
【EXPERT Q&A】What are the requirements for the production of Class I medical devices?

Drugdu.com expert’s response: The production of Class I medical devices requires compliance with the following conditions, covering five core aspects: production facilities, equipment, personnel, quality management systems, and regulatory compliance: I. Production Facilities and Environmental Conditions 1. Facility Requirements Production sites must be clean, suitable, and meet the needs of manufacturing processes and quality control. For example, workshops producing medical cotton swabs must maintain hygiene to prevent microbial contamination. For devices with special environmental requirements (e.g., sterile products), compliance with cleanroom standards (such as YY0033 Management Standard for Sterile Medical Device Production) is mandatory. Production facilities must align with production scale and product characteristics, ensuring rational spatial layout to avoid cross-contamination. 2. Environmental Control Depending on product risk levels, some Class I devices may require controlled environmental parameters like temperature, humidity, or cleanliness. For instance, workshops producing liquid dressings must maintain constant temperature and humidity. II. Production Equipment and Inspection Facilities ...
- Source: drugdu
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- January 5, 2026
Insilico Medicine and Hisun Pharmaceutical Collaborate to Nominate Preclinical Candidate Compound in Just 8 Months

Insilico Medicine Achieves Key Milestone in Collaboration with Hisun Pharmaceutical: Preclinical Candidate Compound Nominated in Just 8 MonthsJanuary 2, 2026 Insilico Medicine (03696.HK), a clinical-stage biotech company pioneering generative AI-driven drug discovery, announced a significant milestone in its collaborative project with Hisun Pharmaceutical (600267.SH) on January 2, 2026. Leveraging its proprietary AI platform Pharma.AI, Insilico Medicine efficiently nominated a Preclinical Candidate Compound (PCC) for the joint program merely eight months after the strategic partnership was established. The collaboration was initiated in April 2025, when Xiao Weihong, Chairman and President of Hisun Pharmaceutical, and Ren Feng, Co-CEO and Chief Scientific Officer of Insilico Medicine, signed a strategic cooperation agreement for innovative drug R&D at Hisun Pharmaceutical’s R&D headquarters. Under the agreement, the two parties agreed to leverage their respective strengths to jointly conduct AI-driven innovative drug discovery for selected targets in specific indication areas. Specifically, Insilico Medicine is responsible for early-stage ...
- Source: drugdu
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- January 4, 2026
Zelgen Biopharma’s Drug-in-Development Sold for Over $1.2 Billion

Cailian Press, December 31 (Reporter: Wu Chao) – Another Chinese pharmaceutical firm has secured a major overseas Business Development (BD) deal exceeding $1 billion for a DLL3-targeted drug. Zelgen Biopharma (688266.SH) has reached an agreement with a global pharmaceutical giant for the worldwide development and commercialization of its core pipeline product, ZG006 (Alveltamig), with a potential total value surpassing $1.2 billion. Zelgen Biopharma announced this evening that it has entered into a strategic collaboration and license option agreement with a holding company of the AbbVie Group (registered in Bermuda, hereinafter “AbbVie”) regarding ZG006. Under the terms, AbbVie will obtain exclusive rights to develop and commercialize ZG006 outside of Greater China (including Mainland China, Hong Kong, Macau, and Taiwan), while Zelgen retains all rights within the Greater China region. According to the agreement, Zelgen will receive an upfront payment of $100 million, plus near-term clinical milestone payments and license-option-related payments of ...
- Source: drugdu
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- January 4, 2026
Rongchang Bio’s “Vidicituzumab” is proposed to be included in the Breakthrough Therapy list for a new indication

On December 31, the CDE website showed that Rongchang Bio’s vidicetuzumab is proposed to be included in the Breakthrough Therapy list for a new indication, in combination with trastuzumab and toripalimab as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma with high HER2 expression . Vidicetumab has been included in the Breakthrough Therapy designation three times before . If it passes the public announcement this time, it will become the drug’s fourth Breakthrough Therapy designation . Vidicetumab is a HER2-targeted ADC drug developed by Rongchang Biotechnology. Through a “precision burst” mechanism, it can not only kill HER2-highly expressing tumor cells, but also attack neighboring HER2-low-expressing cells through the “bystander effect.” Since its initial approval in 2021, this product has been approved for three indications : HER2-overexpressing locally advanced or metastatic gastric cancer that has received at least two types of systemic chemotherapy ; Patients with previously received systemic chemotherapy and HER2-overexpressing ...
- Source: drugdu
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- January 4, 2026
Xingmeng Biotech obtains its first international GMP certification, accelerating the global rollout of its innovative monoclonal antibody drug, Cribi®.

On December 31, 2025, Xingmeng Biopharmaceutical (Suzhou) Co., Ltd. (“Xingmeng Biopharmaceutical”) announced that it had officially obtained the Good Manufacturing Practice (GMP) certificate for pharmaceuticals issued by the Turkish Pharmaceutical and Medical Devices Authority (TITCK) . This certification is not only Xingmeng Biopharmaceutical’s first overseas GMP certificate , but also signifies that the production quality management system of its independently developed core product, Zamerovic-Mazoprevir Injection (trade name: Cribi®), has reached international standards, obtaining key qualifications for this innovative product to enter the mainstream global market. The official GMP compliance on-site inspection by the Turkish authorities was conducted from September 15th to 19th, 2025. Following a rigorous audit, TITCK announced at the closing meeting that the Xingmeng Suzhou production base had achieved the highest level of compliance, “Class I.” According to procedure, TITCK officially issued the GMP certificate on December 18th, 2025. Image: GMP certificate issued by the Turkish Medicines and ...
- Source: drugdu
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- January 4, 2026
The battle between Novo Nordisk and Eli Lilly for market dominance is spreading eastward

In recent years, the weight-loss drug market has been primarily focused on the United States and Europe , revolving around price, affordability, health insurance negotiations, and market penetration caps. However, with several GLP-1 drugs completing their initial market rollout in major global markets, competition is extending to new variables. Against this backdrop, India has gradually come into focus . Competition surrounding the Indian market has become continuous and traceable, making Eli Lilly and Novo Nordisk’s strategies in this market a key point to watch in the 2026 weight-loss drug competition. 01 Ozempic launches in India. The pricing standards are intriguing. Novo Nordisk recently launched Ozempic in India and announced the full dosage gradient and monthly pricing at the same time . Specifically, Ozempic is available in India in three strengths: 0.25 mg, 0.5 mg, and 1 mg, all as pre-filled syringes; the monthly prices are 8,800 rupees ($98), 10,170 rupees ...
- Source: drugdu
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- January 4, 2026
The “Cold” and “Hot” Sides of the Nuclear Medicine Trend

Nuclear medicine , once considered a “niche” field, is now rapidly entering the fast lane of pharmaceutical innovation. Novartis’ Pluvicto surpassed $1 billion in sales in just three years, not only demonstrating the enormous commercial potential of radiopharmaceuticals but also igniting the R&D enthusiasm of pharmaceutical companies worldwide. In China, driven by both favorable policies and technological innovation, the radiopharmaceutical market is transitioning from a period of stagnation to full-scale explosive growth. However, behind this seemingly prosperous track lie multiple challenges, such as target homogenization, tight supply of nuclides, and high technological barriers. 01 The rise of a multi-billion dollar industry Amidst the global wave of pharmaceutical innovation, radiopharmaceuticals are emerging at an astonishing pace, becoming a “new blue ocean” for capital and pharmaceutical companies. In 2023, the global radiopharmaceutical market reached $10.7 billion, and is projected to climb to $22.8 billion by 2030, representing a compound annual growth rate ...
- Source: drugdu
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- January 4, 2026
D-2570 Demonstrates Excellent Efficacy in Phase II Clinical Trial for Moderate-to-Severe Plaque Psoriasis

Regarding the latest clinical progress of D-2570, InventisBio stated that the Phase III clinical trial for psoriasis is proceeding as scheduled. D-2570 is currently under clinical development for various autoimmune diseases, including psoriasis, ulcerative colitis, psoriatic arthritis, and systemic lupus erythematosus (SLE). In December 2025, results from a Phase II clinical study of D-2570 in treating moderate-to-severe plaque psoriasis were published in the Journal of the American Academy of Dermatology (JAAD, IF: 11.79), a top-tier international journal in dermatology. Data showed that after 12 weeks of treatment, D-2570 exhibited excellent efficacy, significantly outperforming the placebo group across all efficacy endpoints. The results indicated significant improvements in the severity and extent of skin lesions after a short treatment period, demonstrating D-2570’s ability to rapidly alleviate the disease burden for patients. Overall, D-2570 was well-tolerated, with most adverse events being mild to moderate and no serious adverse events (SAEs) reported. Its safety ...
- Source: drugdu
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- January 4, 2026

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