Pharmaceutical company SynCore Biotechnology Co Ltd (杏國新藥) yesterday said that it plans to begin a phase III clinical trial of its new pancreatic cancer drug SB05PC in China, after gaining the approval of the Chinese regulator last month.
As the company has completed a phase II trial for SB05PC in the US, the Chinese National Medical Products Administration (NMPA) approved the phase III trial, a company official surnamed Liang (梁) told the Taipei Times by telephone yesterday.
The company is still looking for hospitals with which to cooperate and finalizing the number of patients, but expects to complete the trial by the fourth quarter of 2021, Liang said.
The drug’s potential in China would be huge, as China has the most patients with pancreatic cancer in the world and the NMPA has not selected a medication to be the first-line treatment, unlike its European counterparts, Liang added.
A first-line treatment is one approved by the regulators as the best treatment. Doctors must adopt it first and cannot easily transfer to other treatments unless the first-line treatment does not work or causes serious side effects.
SynCore has applied for SB05PC to be a first-line treatment in China, Liang said.
The number of patients diagnosed with pancreatic cancer in China totaled 116,300 last year and a total of 110,400 patients died, he said citing WHO data.
Meanwhile, the company’s global phase III clinical trial in seven other nations — Taiwan, the US, France, Hungary, South Korea, Russia and Israel — is progressing smoothly, he said.
In those seven markets, the drug would be used as a second-line treatment in combination with gemcitabine for those who have exhausted commonly prescribed first-line chemotherapy treatments.
The company is to conduct interim analysis of the trial at the end of this year, Liang said.
Based on the results of the phase II trial, the company said it is confident that the phase III trial will meet its primary efficacy endpoint and improve the rates of survival of enrolled patients.
GROWING OWINGS: While Luxembourg and China swapped the top three spots, the US continued to be the largest exposure for Taiwan for the 41st consecutive quarter The US remained the largest debtor nation to Taiwan’s banking sector for the 41st consecutive quarter at the end of September, after local banks’ exposure to the US market rose more than 2 percent from three months earlier, the central bank said. Exposure to the US increased to US$198.896 billion, up US$4.026 billion, or 2.07 percent, from US$194.87 billion in the previous quarter, data released by the central bank showed on Friday. Of the increase, about US$1.4 billion came from banks’ investments in securitized products and interbank loans in the US, while another US$2.6 billion stemmed from trust assets, including mutual funds,
AI TALENT: No financial details were released about the deal, in which top Groq executives, including its CEO, would join Nvidia to help advance the technology Nvidia Corp has agreed to a licensing deal with artificial intelligence (AI) start-up Groq, furthering its investments in companies connected to the AI boom and gaining the right to add a new type of technology to its products. The world’s largest publicly traded company has paid for the right to use Groq’s technology and is to integrate its chip design into future products. Some of the start-up’s executives are leaving to join Nvidia to help with that effort, the companies said. Groq would continue as an independent company with a new chief executive, it said on Wednesday in a post on its Web
JOINT EFFORTS: MediaTek would partner with Denso to develop custom chips to support the car-part specialist company’s driver-assist systems in an expanding market MediaTek Inc (聯發科), the world’s largest mobile phone chip designer, yesterday said it is working closely with Japan’s Denso Corp to build a custom automotive system-on-chip (SoC) solution tailored for advanced driver-assistance systems and cockpit systems, adding another customer to its new application-specific IC (ASIC) business. This effort merges Denso’s automotive-grade safety expertise and deep vehicle integration with MediaTek’s technologies cultivated through the development of Media- Tek’s Dimensity AX, leveraging efficient, high-performance SoCs and artificial intelligence (AI) capabilities to offer a scalable, production-ready platform for next-generation driver assistance, the company said in a statement yesterday. “Through this collaboration, we are bringing two
Even as the US is embarked on a bitter rivalry with China over the deployment of artificial intelligence (AI), Chinese technology is quietly making inroads into the US market. Despite considerable geopolitical tensions, Chinese open-source AI models are winning over a growing number of programmers and companies in the US. These are different from the closed generative AI models that have become household names — ChatGPT-maker OpenAI or Google’s Gemini — whose inner workings are fiercely protected. In contrast, “open” models offered by many Chinese rivals, from Alibaba (阿里巴巴) to DeepSeek (深度求索), allow programmers to customize parts of the software to suit their
RSS