On September 29, Shi Pharma Group signed an exclusive licensing agreement with Jiangsu Conri Pharma on the development and commercialization of JSKN003 in mainland China. JSKN003 is a HER2-targeting bispecific antibody-drug conjugate (ADC) with dual HER2 targeting, giving it stronger internalization induction and bystander killing effects, making it highly active against HER2-expressing tumors. Currently, JSKN003 is undergoing Phase I clinical trials in Australia and Phase I/II and Phase III clinical trials in China. Next, Jinmant Bio (a wholly-owned subsidiary of Chiatai Tianqing Pharmaceutical Group) will be granted exclusive license and sublicensing rights for the development, sales, promised sales, and commercialization of the product. They will bear all clinical development costs and become the sole marketing authorization holder for JSKN003 in Mainland China for that field. According to the agreement, Corning Jerry has the right to receive a total of up to 3.08 billion RMB in upfront and milestone payments, including ...
Recently, the combination antibody of apalutamide toripalimab (QL1706, trade name: Qilu’an, hereinafter referred to as “etuo combination antibody”) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of recurrent or metastatic (R/M) cervical cancer patients who have failed platinum-based therapy. This milestone development not only signifies a major breakthrough in the treatment of advanced cervical cancer in China, but also heralds a new stage of development for cancer immunotherapy.It is reported that the Etu combination antibody is the first dual-function combination antibody targeting PD-1 and CTLA-4 designed and produced by Qilu Pharmaceutical through its self-developed MabPair®️ technology platform. It has shown great potential in the treatment of solid tumors such as cervical cancer, lung cancer, and liver cancer, demonstrating both efficacy and safety. With its unique mechanism, it is at the forefront of the journey of tumor dual immunotherapy strategy!Cervical cancer is the ...
Recently, Ascletis announced that its independently developed small molecule GLP-1R agonist ASC30 is undergoing two Phase I clinical trials in the United States for the treatment of obesity with monthly subcutaneous injections and daily oral tablets. With the launch of these two Phase I clinical trials, Ascletis has officially entered the field of weight loss drugs. This is another highlight of the pipeline after Ascletis announced in April this year that it would focus on the development of core non-alcoholic steatohepatitis (NASH) drugs. Urgent need for a new engine Like most biotechs, Ascletis has also been moving forward by trial and error. However, Ascletis is luckier than most biotechs. It has become famous for its first local original hepatitis C drug Ganovo, which not only broke the monopoly of multinational companies such as Gilead, AbbVie, Bristol-Myers Squibb, and Merck in the domestic hepatitis C drug market, ...
Starting in June 2024, global scholars concerned with HIV prevention will focus their attention on Gilead’s antiviral drug, lenacapavir. At that time, Gilead released the latest data from the PURPOSE 1 trial, which demonstrated that lenacapavir, when administered via two annual injections, resulted in zero infections compared to daily oral PrEP medications. This suggests that, in the absence of successful vaccine development, lenacapavir could potentially serve as a long-lasting preventive alternative. However, whether the results of the PURPOSE 1 trial were a coincidence or a certainty remains unanswered. In September, Gilead further presented results from the PURPOSE 2 trial, indicating a higher likelihood of certainty. The results showed that 99.9% of participants in the lenacapavir group did not contract HIV, representing a 96% reduction in infection risk compared to the placebo group. This might signal that we are approaching an era of highly effective HIV prevention. 01 / The ...
On September 26th, the Shanghai Stock Exchange announced that Hangzhou Jianjia Robot Technology Co., Ltd. (hereinafter referred to as Jianjia Medical) has applied to withdraw its application for listing and therefore decided to terminate the review of its public offering of shares and listing on the Science and Technology Innovation Board. It is reported that Jianjia Robot applied for an IPO on the Science and Technology Innovation Board on April 2, 2023. After a round of inquiries, the Shanghai Stock Exchange reviewed and focused on issues such as orthopedic and dental implant surgical robots, market space, and core technologies. It takes one and a half years from application to termination. Yesterday, Jianjia Robot terminated its IPO, and another equipment company’s attempt to go public failed. The winter of IPO for equipment companies continues. When will spring come? Jianjia Robot has great potential for the future Jianjia Robot was founded in ...
Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
Recently, according to publicly available information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the technetium-99m ([99mTc]) hydrazinonicotinamide polyethylene glycol RGD peptide injection (referred to as “99mTc-3PRGD2”) developed by Ruidiao Pharmaceuticals has been included in the priority review list. This also applies to the injection of toluenesulfonate hydrazone nicotinamide polyethylene glycol RGD peptide. 99mTc-3PRGD2 is a radiolabeled drug conjugate (RDC) independently developed by Ruidiao Pharmaceuticals. It is the first class I new drug for radiologic diagnosis in nuclear medicine in China and the world’s first broad-spectrum tumor imaging agent for SPECT imaging. Notably, the success of this drug’s development will change the current technical status and conventional understanding that SPECT/CT imaging technology in nuclear medicine cannot be used for tumor diagnosis, staging, and efficacy evaluation. According to Ruidiao Pharmaceuticals, 99mTc-3PRGD2 targets integrin and specifically binds to the integrin αvβ3 receptor on tumor neovascularization, demonstrating high ...
Recently, Astellas announced that Japan’s MHLW has approved its ADC drug ennozumab PADCEV and Merck’s K drug as a first-line combination therapy for adult patients with fundamentally unresectable urothelial cancer. With excellent data, this combination treatment regimen was approved by the Japanese MHLW in such a short time after Merck announced on September 4 that it had been approved by the European Commission (EC) as a first-line therapy. However, sporadic victories cannot conceal the plight of K-drugs. For the pharmaceutical industry, the biggest hot spot in the past two weeks is definitely the announcement by Kangfang Biologics on September 8 that ivocilimab has become the world’s first and only single-drug head-to-head phase III clinical study to prove that its efficacy is significantly better than that of pabrolib. The drug Zizumab. On the day the results were announced, Merck’s stock price fell in response, and the dilemma was obvious. Under the ...
On September 26, the field of schizophrenia ushered in a historic moment, when KarXT developed by Karuna was approved by the FDA for marketing. This means that Bristol-Myers Squibb’s tens of billions of bets have succeeded in their first battle. On December 22 last year, Bristol-Myers Squibb spent $14 billion to acquire Karuna for KarXT. KarXT has been approved for marketing, and there is another winner – Zai Lab. Currently, Zai Lab owns the rights to KarXT in Greater China. Considering that there are more than 8 million schizophrenia patients in China, and the introduction cost of Zai Lab is not high, it is expected to obtain sufficient profits. Of course, all this can only be said to have settled, and is not surprising. Most of the existing schizophrenia treatments are old varieties approved in the 1990s. KarXT does not rely on dopaminergic or serotonergic pathways and is the first ...
Cell therapy brings a paradigm revolution that can bring hope for a cure to cancer patients. The first cell therapy product to be launched is Yikaida ® It’s a good example. Cell therapy is a key focus of Fosun Pharma’s future development During a recent interview with Zhang Wenjie, CEO and Chairman of Fosun Pharma, he stated that Fosun Pharma is focusing on niche markets with broad prospects in the pharmaceutical industry. Just this month, Fosun Pharma announced that it will fully control Fosun Kate, which is planning to be renamed Fosun Carey and will serve as Fosun Pharma’s core platform in the field of cell therapy technology, continuing to focus on the field of tumor immunotherapy. It is reported that Fosun Kate, located in Pudong, is planning to build the strongest and most comprehensive cell therapy pipeline in China and even globally. Building a powerful CAR-T product pipeline In ...
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