PharmaFocus Today – Page 85 – media

Hengrui Medicine’s PD-1 combination therapy is re-registered for listing in the United States

On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
- Source: drugdu
- 164
- October 17, 2024
3.7 billion blockbuster antihypertensive drug, Shandong New Era approved for listing!

Yesterday (October 14), the official website of the National Medical Products Administration (NMPA) announced that the Sacubitril Valsartan Sodium Tablets submitted by Shandong New Era Pharmaceuticals were approved and passed the review. Sacubitril Valsartan Sodium Tablets is an antihypertensive drug used for adult patients with chronic heart failure with reduced ejection fraction. As the world’s first breakthrough innovative drug in the field of heart failure treatment, Sacubitril Valsartan Sodium Tablets entered the Chinese market in 2017 for the treatment of heart failure, and was later included in the 2020 National Medical Insurance Catalogue. In June 2021, it was first approved in China for the treatment of essential hypertension. In 2021, in-hospital sales exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%. According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. In the subdivided ...
- Source: drugdu
- 114
- October 17, 2024
Another “hundred-ton” synthetic biology production line was successfully delivered, 60 million yuan!

On September 23, the food additive synthetic biology production line project of the biotechnology company undertaken by Sanxi Group successfully completed all installation and commissioning work and was delivered on schedule, which marked that the project has fully entered the production and operation stage. It is reported that the total investment of the production line is about 60 million yuan, and it is equipped with 4 fully automatic precision fermentation production lines. These production lines are equipped with advanced automated separation and purification systems, which can monitor various key parameters in the production process in real time to ensure comprehensive, efficient and precise control of product quality. The successful delivery of this project not only demonstrates Sanxi Group’s deep technical accumulation in the field of synthetic biology equipment manufacturing, but also reflects its efficient project management and delivery capabilities. In recent years, with the continuous development of technologies such as ...
- Source: drugdu
- 107
- October 17, 2024
Partners with 10 Indian AI Startups

Novo Nordisk recently partnered with 10 Indian artificial intelligence (AI) startups, marking an important moment for the Indian AI ecosystem. The Danish company, best known for its weight loss drug Wegovy, is leveraging AI innovations to streamline operations and improve efficiency. The moves are part of the Danish drugmaker’s expansion plans for operations in Bangalore, which it opened 17 years ago. The center helps manage the vast amounts of data collected about the safety and effectiveness of its drugs, including clinical trial information and reports of potential side effects. One of the factors driving the move is that demand for obesity and diabetes-related drugs is expected to grow, especially as global attention to these health issues grows. By strategically positioning itself in India, one of the world’s largest markets for diabetes drugs, Novo Nordisk expects to meet the growing demand by increasing its production capacity. The partnership also has a ...
- Source: drugdu
- 154
- October 17, 2024
Collaborating with 10 Indian AI startups

These measures are part of the business expansion plan launched by this Danish pharmaceutical company in Bangalore 17 years ago. The center helps manage a large amount of data collected regarding the safety and efficacy of its drugs, including clinical trial information and potential side effect reports. One of the factors driving this initiative is that the demand for obesity and diabetes related drugs is expected to grow, especially with the increasing global attention to these health problems. Through strategic positioning in India (one of the world’s largest diabetes drug markets), Novo Nordisk is expected to meet the growing demand by improving its production capacity. This partnership has also had a broader impact on the operations of Novo Nordisk. It is expected that Novo Nordisk’s Bangalore center will become an approximate mirror of its Danish headquarters within three years. The company plans to increase the number of employees in Bangalore ...
- Source: drugdu
- 115
- October 16, 2024
460 million! Migraine innovative equipment company completes Series B financing

Recently, migraine innovative equipment company ShiraTronics announced the completion of a Series B financing of $66 million (approximately RMB 460 million) to support its innovative migraine treatment system. This round of financing is led by new investor Norwest Venture Partners, with other new investors including Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing. The world’s first medical device to treat migraine ShiraTronics, located in Minneapolis, Minnesota, is a clinical stage medical device company dedicated to developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and was awarded the FDA Breakthrough Device designation in 2021. The name migraine is not unfamiliar and is often heard in daily life, so the migraine market is ...
- Source: drugdu
- 108
- October 16, 2024
Progress has been made in the construction of HSV-1 oncolytic virus where Wuhan virus is located

Recently, Hu Zhihong, Wang Manli, Luo Minhua and Zeng Wenbo from the Wuhan Institute of Virology, Chinese Academy of Sciences, jointly published a research paper entitled “Efficient Strategy for Synthesizing Vector Free and Oncolytic Herpes Simplex Type 1 Viruses” on the international academic journal ACS Synthetic Biology. This research carried out the construction and optimization of an artificial synthesis platform based on type I herpes simplex virus type F, and used this platform to transform oncolytic viruses. Type I herpes simplex virus (HSV-1) has important application prospects as an oncolytic virus in cancer treatment. In this study, the research team developed a new method for efficient synthesis and rescue of HSV-1 virus. Unlike traditional methods of synthesizing complete genomes containing vector sequences in vitro and transfecting them into mammalian cells to rescue viruses, the research team synthesized HSV-1 genome fragments containing homologous arms through transformation related homologous recombination (TAR) in ...
- Source: drugdu
- 130
- October 16, 2024
Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the FDA for the treatment of hemophilia A and hemophilia B

The approval of HYMPAVZI is based on the results of a phase III trial study, which showed that compared with factor based prophylaxis and on-demand treatment, the drug can significantly reduce bleeding rates in eligible hemophilia A and hemophilia B patients without inhibitors. HYMPAVZI is the first weekly subcutaneous injection regimen provided in the United States for eligible hemophilia B patients. At the same time, it is also the first regular treatment provided to eligible hemophilia A and hemophilia B patients through pre filled injection pens or syringes. Recently, Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the US Food and Drug Administration (FDA) for the regular treatment of hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) patients over 12 years old without coagulation factor inhibitors, in order to reduce bleeding episodes. HYMPAVZI is the first and only approved anti tissue factor ...
- Source: drugdu
- 141
- October 16, 2024
The “wolf” is really here, and the elimination of zombie approvals has begun

While the industry is still waiting to see whether the “zombie” approvals will really be eliminated, the new regulations of the National Medical Products Administration have provided a policy basis for the elimination of “zombie” approvals-On October 12, 2024, the National Medical Products Administration issued a notice on the application procedures and application materials requirements for re-registration of domestically produced drugs (No. 38 of 2024), which will be implemented from January 1, 2025. According to the new regulations on re-registration, three types of approvals will face the risk of delisting. The first type of risky products: “zombie” approvals, especially those with missing production scope and production address The “zombie” approvals mentioned above are very likely to be delisted: The “Application Procedures for Re-registration of Domestically Produced Drugs” clearly requires “strengthening the management of drugs that have not been produced on a commercial scale during the period from the approval of ...
- Source: drugdu
- 121
- October 16, 2024
Important document! Secondary bargaining is “stopped”

Regarding the scope of the special rectification of “secondary bargaining” defined in the notice, the author consulted the relevant responsible personnel of the Finance Department of the Hunan Provincial Health Commission, and received the reply: This “secondary bargaining” rectification focuses on the behavior of public hospitals not settling according to the agreed purchase and sale prices in order to obtain irregular rebates. At present, most hospitals in Hunan Province are involved in “secondary bargaining” rebates to varying degrees and in different forms, such as bearing the cost of drug consumption fund recovery and deducting penalties for excessive drug use as the name and method of rebates. The rebate income from “secondary bargaining” is used by hospitals to supplement related operating costs. This time, the Hunan Provincial Health and Health System carried out a special rectification work on “secondary bargaining” of drug consumption, requiring it to be completed in October. In ...
- Source: drugdu
- 202
- October 16, 2024

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