PharmaFocus Today – Page 9 – media

Opportunity moment for Chinese ADC

Recently, Eli Lilly announced that its Nectin-4 targeted ADC drug LY4052031 has suspended clinical trials due to safety issues. Nectin-4 is a hot target for ADC drug development. Currently, only one Nectin-4 targeted ADC product has been approved for marketing in the world, namely Padcev, which is approved for the treatment of urothelial carcinoma. Eli Lilly has deployed two next-generation anti-nectin-4 ADC drugs: LY4052031 (the toxin is the DNA topoisomerase I inhibitor camp98) and LY4101174 (the toxin is exatecan). This suspension involves LY4052031, while LY4101174 is still in Phase I clinical trials, and its efficacy and toxicity in humans remain to be observed. This incident also aroused the industry’s attention to the safety of Nectin-4 ADC, and exposed the difficulties in the research and development of ADC drugs: payload toxicity control, linker stability, any “shortcomings” in any link may trigger a chain reaction. 1. China’s Biotech industry faces opportunities Nectin-4 ...
- Source: drugdu
- 61
- May 20, 2025
Mabwell Biopharma and Shenshi Technology have reached a strategic cooperation to build a large model platform for biopharmaceutical R&D

On May 14, Mabwell Biotech and Shenshi Technology jointly announced a strategic cooperation. Both parties will give full play to their respective strengths in biopharmaceutical research and development and artificial intelligence.(AI) big model advantages, jointly build a big model platform for biopharmaceutical R&D, and jointly build innovative drugs Develop a new paradigm. Mabwell Biopharma has outstanding advantages in the construction of ADC technology platforms and the discovery of single/double antibody molecules, and has opened up the entire industry chain of ADC drugs from research and development to production. The independently developed IDDC platform and Mtoxin toxin technology have been verified in many projects. Shenshi Technology has built a complete microscopic world cognition and computing system with its independently developed Uni-Smart scientific literature multimodal model, Uni-Mol molecular conformation model and Uni-Fold protein folding model and other series of life science models. The two parties will cooperate in two directions: First, knowledge ...
- Source: drugdu
- 63
- May 19, 2025
CanSino’s inhaled tuberculosis vaccine approved for clinical trials in Indonesia

May 15, CanSino(688185/06185) announced that the company’s inhaled tuberculosis vaccine (adenovirus type 5 vector) has recently obtained clinical trial approval from the Indonesian Food and Drug Administration. The development of this vaccine aims to solve the problem of BCG’s weakening protection over time and provide more effective immune protection. According to the World Health Organization, there will be 10.8 million new tuberculosis patients worldwide in 2023, showing the continued threat of tuberculosis, especially in Southeast Asia and Africa. This Phase I clinical trial will explore the safety and immunogenicity of the vaccine in adults aged 18-49. In the first quarter of 2025, CanSino Biologics achieved revenue of 137 million yuan and a net profit attributable to shareholders of the parent company of -11.55 million yuan. https://finance.eastmoney.com/a/202505153405639359.html
- Source: drugdu
- 69
- May 19, 2025
Xinghao Pharmaceutical’s Docetaxel Injection Receives FDA Approval of Abbreviated New Drug Application (ANDA)

On May 15, Xinghao Pharmaceutical announced that Guangdong Xinghao Pharmaceutical Co., Ltd. recently obtained approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for docetaxel injection. This approval qualifies the company to sell the drug in the U.S. market, marking an important step for the company in expanding overseas markets. Docetaxel injection is indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer and head and neck cancer. The dosage form is injection with specifications of 80mg/4mL and 20mg/1mL. In the first quarter of 2025, Xinghao Pharmaceutical achieved revenue of 142 million yuan and net profit attributable to shareholders of the parent company of 25.03 million yuan. https://finance.eastmoney.com/a/202505153405776677.html
- Source: drugdu
- 63
- May 19, 2025
North China Pharmaceutical’s subsidiary’s recombinant tetanus vaccine approved for clinical trials

On May 15, North China Pharmaceutical(600812) announced that its subsidiary Jintan Company recently received the “Drug Clinical Trial Approval Notice” for the recombinant tetanus vaccine (Escherichia coli) approved and issued by the National Medical Products Administration. The acceptance number of the notice is CXSL2500168, the notice number is 2025LP01313, the dosage form is injection, the specification is 30μg/0.5ml/piece, and the approval conclusion shows that the vaccine meets the relevant requirements for drug registration and agrees to conduct clinical trials. As of April 2025, Jintan’s cumulative R&D expenses for this drug are RMB 39.71 million (unaudited). Currently, there is no recombinant tetanus vaccine based on genetic engineering on the market at home and abroad, and Jintan’s R&D will fill this market gap. In the first quarter of 2025, North China Pharmaceutical achieved revenue of 2.574 billion yuan and net profit attributable to shareholders of the parent company of 57.49 million yuan. ...
- Source: drugdu
- 71
- May 19, 2025
The National Medical Products Administration approved the marketing of velaglucerase beta for injection

On May 15, the National Medical Products Administration approved the marketing of velaglucerase beta for injection (trade name: Gorenin) applied by Beihai Kangcheng (Shanghai) Biotechnology Co., Ltd. through the priority review and approval procedure. It is suitable for long-term enzyme replacement therapy for adolescents and adults with type I and type III Gaucher disease aged 12 and above. Gaucher disease is an autosomal recessive metabolic disease caused by functional defects of glucocerebrosidase in lysosomes and is included in the “First List of Rare Diseases”. Velaglucerase beta for injection can reduce the storage of glucocerebroside in the body, thereby exerting a therapeutic effect. The listing of this variety provides a new treatment option for related patients. 网址：https://finance.eastmoney.com/a/202505153405858055.html
- Source: drugdu
- 56
- May 19, 2025
GlaxoSmithKline to buy Boston Pharmaceuticals unit for up to $2 billion

GlaxoSmithKline and Boston Pharmaceuticals announced on May 14 that they have reached an agreement for GlaxoSmithKline to acquire BP Asset IX, a subsidiary of Boston Pharmaceuticals, to obtain the sales rights of Efimosfermin, a Phase III clinical-ready, investigational specialty drug for the treatment of fatty liver disease (SLD). Under the agreement, GlaxoSmithKline will pay an upfront payment of $1.2 billion and may pay additional milestone payments totaling up to $800 million. 网址：https://finance.eastmoney.com/a/202505143404307664.html
- Source: drugdu
- 67
- May 19, 2025
The King of Autoimmune drugs Competition

Previously, Sanofi and Regeneron announced that the FDA has approved a new indication for Dupilumab for the treatment of chronic spontaneous urticaria (CSU) in children and adults aged 12 years and older that is not well controlled with H1 antihistamines. It is worth mentioning that Dupilumab is the first targeted treatment for CSU in the United States in more than a decade. This progress not only consolidates the core position of Dupilumab in the field of autoimmune therapy, but also brings the competition for the “king of autoimmunity” into a white-hot stage. This battle between dragons and tigers for the “autoimmune overlord” has just begun. 1. Self-immunity pioneer The autoimmune field has always been a battleground for pharmaceutical companies, and AbbVie was once the undisputed king of this field. According to Frost & Sullivan data, from the perspective of the global autoimmune market, autoimmune diseases are the second largest drug ...
- Source: drugdu
- 64
- May 19, 2025
Introduction to the new INN naming scheme for monoclonal antibody drugs

The International Pharmaceutical INN Name Expert Group (INN Expert Group) decided to implement a new scheme for naming monoclonal antibody drugs at the 73rd INN Consultative Meeting in October 2021. The new scheme aims to avoid the confusion caused by the use of the “-mab” root in the old naming scheme, divides monoclonal antibody drugs into four different groups, and introduces four completely new root words. 1. Background and purpose of the new naming scheme Old naming scheme: Previously, monoclonal antibody drugs used “-mab” as the root word, but with the development of technology, this naming method can no longer accurately distinguish different types of monoclonal antibodies. New naming scheme: The new scheme divides monoclonal antibody drugs into four groups, each using a unique root word to more accurately describe the characteristics of the drug. 2. Four new root words and their meanings -tug: for “unmodified immunoglobulin” class of mAbs, ...
- Source: drugdu
- 71
- May 19, 2025
China and the United States reduce their reciprocal tariffs to 10%

From May 10 to 11, high-level economic and trade talks between China and the United States were held in Geneva, Switzerland. After the talks, the two sides issued a joint statement today (May 12). The main contents are as follows: The Chinese chief negotiator for China-US economic and trade relations, Vice Premier He Lifeng, and the US chief negotiators, US Treasury Secretary Jeff Bessant and Trade Representative Greer, and other representatives of their respective governments, had candid, in-depth and constructive communication on the implementation of the important consensus reached in the phone call between the Chinese and US heads of state on January 17, and the talks made substantial progress. The United States will (i) modify the additional ad valorem tariffs on Chinese goods (including goods from the Hong Kong Special Administrative Region and the Macao Special Administrative Region) imposed by Executive Order No. 14257 of April 2, 2025, by ...
- Source: drugdu
- 62
- May 19, 2025

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