Introduction: The origin research of Omicron is questioned; the first CD19 CAR-T therapy in China has been submitted for listing application; Sipai Health is expected to be launched on December 23... Biological Exploration will pay attention to the "medicine" news and explore the value of biotechnology!
01 Omicron origin research is questioned
Recently, a study said that the ancestors of the new crown variant Omicron spread in Africa three months before their discovery, which triggered heated debate. The findings challenge the mainstream theory that Omicron evolved from long-term infections in people with immune system impaired. Critics say the coronavirus sequence detected by the study may have originated from laboratory contamination. "This doesn't look like the evolution of the coronavirus," said molecular epidemiologist Joel Wertheim. The team that reported the results is re-examining the data.
02 The first CD19 CAR-T therapy in China
submitted an application for marketing
1 On November 14, Heyuan Biotechnology (Tianjin) Co., Ltd. (hereinafter referred to as "Heyuan Bio") announced that the National Drug Administration (NMPA) has officially accepted its application for the launch of new drugs to target CD19 CAR-T therapy Hkilensai Injection (proposed) for the treatment of relapsed or refractory B-cell acute lymphocytic leukemia (r/r B-ALL) in adults.
Hekilente Injection (Proposed) (CNCT19 Cell Injection, Inaticabtagene Autoleucel) is the first CAR-T cell therapy product in the field of leukemia in China to be accepted for the application for new drugs on the market and is expected to be the first approved CAR-T cell therapy product. It is also the first fully independently developed targeted CD19 CAR-T cell therapy product in China. The therapy has been awarded the Breakthrough Therapeutic Drug Certification (BTD) from the National Drug Administration Drug Review Center (CDE) and the Orphan Drug Qualification Certification (ODD) from the US FDA.
The application for marketing of this new drug is based on the results of a single-arm, open, multicenter pivotal clinical study of Hekilente injection for the treatment of r/r B-ALL: Hekilente injection showed a long-lasting high response rate and significantly reduced toxicity severity associated with CAR-T treatment in adult patients with r/r B-ALL.
03 Siludi listed on the Hong Kong Stock Exchange
Today, Siludi officially listed on the Hong Kong Stock Exchange with an issue price of HK$24.98 per share, with a total of 16.35 million shares issued, jointly sponsored by CICC and CITIC Construction Investment International. 3D Medicines Inc ("Siludi") is an biomedical company dedicated to developing oncology drugs for cancer patients, especially those who require long-term treatment.
As of now, Siludi has established a product pipeline containing a core product and 11 candidate drugs, including tumor immunotherapy monotherapy, candidate drugs with a mechanism of action that can be used in combination with pipeline products, and pain management assets. Among them, the core product, Envolizumab, is the pillar product of Siludi. It was approved in November 2021 and commercialized in December 2021; there are seven other candidate drugs in the clinical stage, and three of them have entered the Phase II/III critical trials.
04 Shuobai Pharmaceutical Innovative Drug
DBM-1152A was accepted by CDE
Recently, the First in Class (FIC) innovative drug DBM-1152A inhaled solution jointly applied by Beijing Shuobai Pharmaceutical Technology Co., Ltd. and Anhui Shuobai Pharmaceutical Co., Ltd. have officially received CDE acceptance, and will become the fourth new chemical drug in Shuobai Company to enter clinical research.
DBM-1152A is another innovative drug molecule developed by the Shuobai R&D team in the field of respiratory disease treatment since 101BHG-D01. It also has two functions: M receptor antagonism and β receptor agonism (MABA), and has synergistic dilation of the trachea and anti-inflammatory effects. It is intended to be used for asthma and chronic obstructive pulmonary diseases , including chronic bronchitis , emphysema , and bronchospasm caused by emphysema .
05 The first domestic potassium-lowering
polymer innovative drug was approved for clinical
November 14, the official website of CDE showed that the Class 1 new drug WS016 dry suspension independently developed by Sino-US Huashitong Biomedical Technology (Wuhan) Co., Ltd. (hereinafter referred to as "Sino-US Huashitong") was approved for clinical trials, and clinical research on hyperkalemia will be carried out in the future.
WS016 dry suspension is an oral novel polymeric drug. It does not enter the blood system and binds potassium ion highly selectively in the gastrointestinal tract. The drug and the binding part are then removed from the body through the fecal pathway. It has good safety and can significantly improve clinical compliance. It can be taken for a long time to effectively control the blood potassium level, providing a new choice for the clinical treatment of hyperkalemia. WS016, as a new treatment plan for long-term potassium reduction and potassium control, will also benefit the majority of hyperkalemia patients and produce good economic and social effects.
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