New Deal: The pricing of innovative drugs may be further relaxed
On February 6, a letter titled "Notice on Soliciting Opinions on Establishing a Mechanism for the Initial Issuance of Newly Listed Chemical Drugs and Encouraging High-quality Innovation" was circulated, and the document was stamped by the National Medical Security Administration's Pharmaceutical ** Bidding and Procurement Division, dated February 5.
According to the Opinion Letter, in order to encourage clinical value-oriented drug R&D and innovation, support the diversified supply and fair access of high-quality innovative drugsImprove the market-led drug formation mechanismThe Health Insurance Bureau expects all units and associations to listen to and collect the opinions and suggestions of relevant pharmaceutical companies.
The outflow of the document was interpreted by industry personnel as a further "loosening" of innovative drugs. Previously, under the influence of medical reform systems such as centralized procurement and medical insurance negotiations, innovative drugs faced certain pricing pressure after they were launched, which would also be directly reflected on the investment side. At this time, the Health Insurance Bureau issued relevant documentsIt may bring new opportunities to the domestic innovative drug industry.
New Deal: Cells and genes will become one of the key tasks of Beijing in 2024
On February 1, the Beijing Municipal People's Government issued a notice on the "List of Key Tasks of the 2024 Municipal Work Report", requiring all departments to work together to promote development.
The list indicates Beijing's priorities in a number of areas in 2024. In the field of health, the "List" proposes to give full play to the advantages of clinical research quality and efficacy, strengthen the research and development of original innovative drugs and high-end medical devices, give full play to the role of drug and medical device innovation service stations, strive for the pilot of accelerated review policies for innovative drugs and medical devices, and improve the process of innovative drugs entering hospitals. Strengthen the layout of cutting-edge emerging fields such as cell gene ** and synthetic biological manufacturing, and promote the formation of a cluster development trend.
New clinical trial: FDA approved co-species allogeneic δ2 T cells** for clinical use
On February 5, the American biopharmaceutical company AcePodia announced that itsAllogeneic delta 2 T cells**ACE2016Approved by the FDA to conduct clinical trials for**Solid tumors with positive EGFR expression
It is understood that AcePodia emphasizes its use of an antibody-cell conjugation (ACC) platform to target tumors with its proprietary immune cells, such as:-Delta T cells are linked to readily available natural killer (NK) cellsto create novel antibody cell effectors (ACEs)**The company's current ACE** product pipeline is such as natural killer (NK) cells or delta T cells.
To date,The total amount raised by AcePodia reached 2$5.9 billion, including investments from Yahoo founder Zhiyuan Yang and Foxconn founder Terry Gou. In addition,JW Therapeutics reached an agreement with AcePodia in 2020, obtained exclusive priority authorization for clinical and commercial trial and commercialization of related cells** in Chinese mainland, Hong Kong and Macau.
New clinical trial: Xiankangda Life's first "off-the-shelf" NK cells** began clinical research
On January 29, Xiankangda Life WeChat *** released a message saying:The company's first clinical trial of "off-the-shelf" NK cells (PANk-003) combined with postoperative standard adjuvant chemotherapy** solid tumors was launched in Anyang Cancer HospitalThe kick-off meeting was presided over by the PI of the project, Li Baozhong, President and Chief Physician of Anyang Cancer Hospital, and attended by Zhang Yaowen, Vice President of Anyang Cancer Hospital, Liu Yazhou, Director of Clinical Operations of Xiankangda Group, and the clinical research teams of both parties.
According to Xiankangda Life, PAN003 is an allogeneic NK cell preparation with a purity of more than 95% and no risk of **HD. PANK-003** is the peripheral blood of healthy adults aged 18-30 yearsDifferent from other ** NK cells, it has high expression of CD16 and NKG2D, which has higher killing activity against tumor cells, and can achieve better killing effect through inhibitory KIR-HLA mismatch between recipient and donor.
The main purpose of this project is to evaluate the safety and tolerability of PAN003 combined with postoperative standard adjuvant chemotherapy in patients with ** solid tumors, and to determine the maximum tolerated dose and subsequent ** recommended dose, which is applicable to patients with postoperative standard adjuvant chemotherapy for solid tumors.
New clinical: the first domestic research on the preparation of exosomes using three-dimensional large-scale technology
Recently, the clinical research project jointly carried out by Zhongke Ruiji Company and the Eye Hospital Affiliated to Wenzhou Medical University - "Safety and Efficacy Study of Mesenchymal Stem Cell Exosomes** Primary Sjögren's Syndrome-related Dry Eye" has been successfully filed by the National Health Commission (record number: MR-21-22-012280).This project is the first clinical study in China to use three-dimensional large-scale technology to prepare exosomes for dry eye disease**.
The trial is based on the DASEA bio-intelligent manufacturing platform. It is understood that as of February 3, 2024, through cooperation with biomedical companies and hospitals, a total of 4 preclinical studies of stem cells and exosomes prepared by DASEA bio-intelligent manufacturing platform technology have been approved for clinical trials, 3 are applying for IIT, and 10 are undergoing preclinical research.
New data: BMS and Johnson & Johnson CAR-T product revenue released
Recently, Bristol-Myers Squibb (BMS) announced its 2023 results: total revenue of 4500.6 billion US dollars, down 2% year-on-year. Among them, the sales of the PD-1 inhibitor Opdivo (commonly known as "O drug") were 9 billion US dollars, a year-on-year increase of 9%. It should be noted that O drug will face patent expiration in the United States in 2028.
At the same time,BMS's data on two approved CAR-T products were also released, with a total revenue of 8$3.6 billion.
Just in late January, Johnson & Johnson released its 2023 annual report: full-year sales for fiscal 2023 reached $85.2 billion, up 65%。Among them,Carvykti, a CAR-T product from Legend Biotech, achieved annual sales of $500 million.
Industry dynamics: CanSino "relinquishes" control of its subsidiary
On the evening of February 2, CanSino issued an announcement that it would no longer refer to its subsidiary Shanghai Shanghai Pharmaceutical CanSino Biopharmaceutical"Medica CanSino") into the scope of consolidated statements.
Shanghai Pharmaceutical CanSino is a new crown vaccine production base jointly invested by Shanghai Pharmaceutical, CanSino Biologics and Shanghai Biopharmaceutical Industry Equity Investment**It is mainly engaged in the production of recombinant novel coronavirus vaccine (adenovirus type 5 vector) Keweisha.
CanSino's interpretation of this behavior is: the company and Shanghai Biomedical Industry Equity Investment Partnership (Limited Partnership) (hereinafter referred to as"Industrial Investment**"The initial cooperation period agreed in the agreement signed by CanSino Concerted Actors has expired, and the agreement will be automatically terminated. Upon automatic termination of the Concert Party AgreementThe company no longer controls more than half of the equity voting rights and more than half of the board of directors seats, and cannot control CanSino.
But the industry believes that the real reason for CanSino's moveIt is to reduce the impact of the new crown vaccine business represented by Shanghai CanSino on the performance. Previously, when it was controlled by CanSino, CanSino often dragged down CanSino's performance. In the two years of 2022 and 2023, the total loss of Shanghai Pharmaceutical CanSino will reach 103.9 billion yuan.
The earnings season is coming, and the poor performance in 2023 can no longer be blamed on the new crown.