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研发项目又遭砍,上海医药1.15亿研发资金要打水漂了?|速读公告

Another R&D project has been canceled. Will sh pharma's R&D funding of 115 million yuan be wasted? | Quick read announcement

cls.cn ·  Jun 7 20:33

Tonight, sh pharma announced that it has decided to terminate clinical trials and subsequent development of four research and development projects involving indications such as B-cell non-Hodgkin's lymphoma and multiple sclerosis. The accumulated research and development investment in the early stage has reached 115 million yuan. Industry experts believe that factors such as effectiveness not meeting expectations, better effects of similar competing products, and increased uncertain factors in research and development may cause the company to terminate its in-research projects.

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Shanghai Pharmaceuticals (601607.SH) has decided to terminate seven research and development projects within two months, in order to "reasonably allocate research and development resources and focus on advantageous research and development projects."

Industry experts analyzed and considered that factors such as unexpected efficacy during the research and development process, better performance of similar competitive products, and increased uncertainty in research and development could all lead to the termination of a company's research projects. However, if there are suitable opportunities in the future, they may be restarted.

Shanghai Pharmaceuticals announced tonight that the four pipelines terminated in research involved indications such as B-cell non-Hodgkin's lymphoma and multiple sclerosis. The cumulative research and development investment amounted to RMB 115 million.

Shanghai Pharmaceuticals announced that, in order to "reasonably allocate research and development resources, focus on advantageous research and development projects, and comprehensively evaluate the future market value, business synergy, and subsequent development input, etc." the company decided to terminate the clinical trials and subsequent development of four R&D projects: B001, B001-A, I022 (combination therapy of breast cancer, first-line treatment) and I022-K.

Specifically, B001 is a therapeutic biological product for the treatment of CD20-positive B-cell non-Hodgkin's lymphoma, and the project, which was approved for clinical trials in August 2016, is currently in the phase I clinical trial ending stage. The rational cumulative research and development investment amounted to about RMB 64.6668 million and is intended for clinical development for the treatment of B-cell non-Hodgkin's lymphoma.

B001-A is a novel human recombinant monoclonal antibody product identical to B001, intended for the treatment of multiple sclerosis (MS), and which was approved for clinical trials for this indication in June 2021. The clinical trials have not been initiated yet, and this time it is intended to terminate clinical R&D for MS. The project's rational cumulative research and development investment amounted to about RMB 5.9346 million.

I022 is an innovative chemical medicine type 1 small molecule drug, intended for the treatment of advanced breast cancer/liposarcoma and other indications; in combination with letrozole, intended for first-line treatment of breast cancer; in combination with endocrine drugs, intended for treatment of breast cancer recurrence; in combination with cabozantinib, intended for the treatment of liposarcoma. This time, it is only intended to terminate clinical development for the indication of first-line breast cancer treatment. This project was granted approval for clinical trials by the National Medical Products Administration in May 2020 and is currently in the phase II clinical trial ending stage. The rational cumulative research and development investment amounted to about RMB 6.9937 million for the indications involved in the termination. Clinical trials and subsequent development for other indications are still ongoing.

I022-K is an innovative chemical medicine type 1 small molecule drug for the treatment of advanced solid tumors. This project was granted approval for clinical trials by the National Medical Products Administration in August 2021 and is currently in the phase I clinical trial ending stage. This time, it is intended to terminate the subsequent development of the drug. The rational cumulative research and development investment amounted to about RMB 36.999 million.

In fact, it was only on May 1 that Shanghai Pharmaceuticals announced the termination of three R&D projects including I010, B002, and B003, which were involved in malignant tumors such as non-small-cell lung cancer (NSCLC), HER2-positive metastatic breast cancer, and neoadjuvant therapy for HER2-positive breast cancer and late-stage or metastatic breast cancer. The cumulative R&D investment amounted to RMB 47.599 million, RMB 132.8 million, and RMB 141.4 million respectively. According to the 2023 annual report, as measured by indication, Shanghai Pharmaceuticals had 55 innovative drugs in development.

"Developing innovative drugs, such as biopharmaceutical research and development, requires a lot of resources," said industry expert Li Changcheng in an analysis to Caixin reporters. There are many risks in the research and development process, and some drugs may not achieve the expected efficacy during research and development. Moreover, other companies may develop products with better performance, at which point the company may decide that it is no longer meaningful to continue. Although the market prospects of the research projects terminated by Shanghai Pharmaceuticals this time were promising, there are many enterprises researching similar products, and competition is fierce. Secondly, the current global economic situation has led to increased uncertainty in research and development, and it is better to pause and play it safe.

As for the R&D funds that have already been invested, Li Changcheng believes that "it is not necessarily a waste, and if there are suitable opportunities in the future, under the condition of social and economic development, the project may be restarted."

The translation is provided by third-party software.


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