Dandelion Bio·News | Biopharma Industry Weekly Headlines (July 4–10)
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1、CDE | Public consultation, involving antibody drugs and gene therapy products
July 5, 2024 - July 9, 2024CDE Public ConsultationOpinion:Technical Guidelines for Non-Clinical Research of Adeno-Associated Virus Vector Gene Therapy Products (Draft for Comments)、Technical Guidelines for Clinical Pharmacology Studies of Antibody Drugs (Draft for Comments) and Technical Guidelines for Drug Exposure-Effect Relationship Studies (Draft for Comments)，And release
Technical Guidelines for Pharmaceutical Research of Generic Oral Solutions of Chemical Drugs、Technical Guidelines for Overfilling Studies of Chemical Generic Drug Injections。 (Click on the file name to viewRelated Reading）
(Source：National Medical Products AdministrationDrug EvaluationCenter, Dandelion Ouryao）
2. National Medical Products Administration Special Drug Inspection Center | Soliciting Opinions: "Radiopharmaceutical Production Inspection Guidelines"
On July 10, 2024, the Inspection Center of the National Medical Products Administration and the Special Drug Inspection Center of the National Medical Products Administration issued a notice soliciting public opinions on the "Radiopharmaceutical Production Inspection Guide."Deadline for comments: July 17。 （Related ReadingClick to view)
(Source：National Medical Products AdministrationFood and Drug Review and InspectionCenter, Dandelion Ouryao）
3. Shanghai Medical Products Administration | Public Consultation on the "Shanghai Supervision and Management Regulations for Autologous Chimeric Antigen Receptor T-Cell (CAR-T)"
On July 10, 2024, the Shanghai Municipal Drug Administration revised the "Interim Regulations on the Supervision and Management of Autologous Chimeric Antigen Receptor T-Cell (CAR-T) in Shanghai" (Hu Yao Jian Gui [2022] No. 3), forming the "Regulations on the Supervision and Management of Autologous Chimeric Antigen Receptor T-Cell (CAR-T) in Shanghai (Draft for Comments)", which is now open for public comments. All sectors of society are welcome to provide opinions and suggestions.The deadline for feedback on opinions and suggestions is August 11, 2024.
(Source：Shanghai Municipal Medical Products Administration
Recipient
Li
Context
Condition
CDE Acceptance Status
July 4, 2024From July 1 to July 10, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 436 drug applications were accepted., among which52 Biologics（19 new drugs and 1 imported, see the figure below).
(Source: Center for Drug Evaluation, National Medical Products Administration)
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According to the terms of the agreement, IASO Bio will purchase the relevant rights owned by Innovent Bio under the original BCMA CAR-T cooperation agreement at the agreed price.At the same time, Innovent Bio will invest in IASO Bio at the same price.Will hold 18% of IASO Bio's shares after the investment.。Under the new strategic cooperation framework, the two parties will achieve a high level of resource integration in the field of cellular immunotherapy.IASO Bio will obtain Fokusu®(Idecabtagene Vicleucel Injection) global market commercialization rights and intellectual property licensing, etc., and independently responsible for and make decisions on the product's development, production, and sales;At the same time, Innovent Bio became a strategic shareholder of IASO Bio.
(Source: IASO Bio Official WeChat)
2024Year JulyOn the 8th, Eli Lilly announced that it has agreed to acquire for $3.2 billionMorphic Therapeutics，Eli Lilly will obtain an experimental therapy for treating inflammatory bowel disease (IBD) and other chronic conditions.
Source of the image: Conmena Corporate Announcement
According to the license agreement, Connoymab granted Belenos globally (Remove Large and MediumChina Region) The exclusive rights to develop, manufacture, and commercialize the group's candidate drugs CM512 and CM536(Research, Development, Registration, Production and Commercialization).CM512 and CM536 are both independently developed by ConnaMed.Bispecific Antibody。CM512 filed an IND application in May this year, and CM536 is in the preclinical stage.
AsConsideration, Chengdu Keymed will charge$15 million in upfront and near-term payments, while One Bridge Hong Kong Holding Limited ("One Bridge Hong Kong",Wholly-owned subsidiary of the group）Will charge Belenos approximately 30.01%The equity.After achieving a number of development, regulatory, and commercial milestones, Chengdu Keymed is also entitled to receive up to$1.70 billionAdditional payment.
(Source:PharmSnap Headlines）
2024On July 10, the CDE official website showed that the respiratory syncytial virus mRNA vaccine developed by CSPC Jushi Biopharmaceutical Co., Ltd. has obtained clinical trial implied permission, with its indication being the prevention of lower respiratory tract diseases caused by respiratory syncytial virus infection.
Currently, there are only 2 RSV vaccines available in the global market:
A product byRSVPreF3 Vaccine (Arexvy) Developed by GSK, which was approved by the FDA on May 3, 2023, with sales reaching $1.55 billion in 2023;
Another product byRSV Vaccine (Abrysvo) Developed by Pfizer, which was approved by the FDA on May 31, 2023, with sales of $890 million in 2023.
The two RSV vaccines that have been marketed globally are both recombinant protein subunit vaccines.Currently, no RSV vaccines have been approved for marketing in China.。
(Source: CDE official website, Pharmaceutical Observer)）
July 2024On the 5th, according to the announcement on the CDE official website, Qilu Pharmaceutical's Trastuzumab for Injection (trade name: Anquluo)®) has officially received marketing approval for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
According to reports,Trastuzumab, the original research drug developed by Roche, is a humanized monoclonal antibody targeting HER2., one of the "three key oncology products" under Roche. This product is currently the internationally recommended standard treatment for HER2-positive breast cancer and gastric cancer in the medical community., was approved for marketing in the United States in 1998 under the trade name Herceptin.In 2002, trastuzumab was approved to enter the Chinese market.
August 2020,The first domestically produced trastuzumab (trade name: Hanshu You) independently developed and manufactured by Henlius has been simultaneously launched in China and the EU., and its 60mg specification was also approved in August 2021. In February 2023, Bright Biology's wholly-owned subsidiaryHisun BioThe trastuzumab for injection has been approved for marketing, becoming the second domestically produced option in China. July 2023 and October 2023,Chia Tai Tianqing and Anke BioThe trastuzumab products have also been successively approved for marketing.
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not reflect the position of any organization or this official account. If there are any inaccuracies, please kindly point them out. For reprints, please indicate the author and source:蒲公英Biopharma.
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