Zanubrutinib Generics Barred from U.S. Market Until 2037; Chipscreen Biosciences Announces Proposed Private Placement Raising Up to RMB 960 Million
BeOne
Developer of Molecular Targeted and Immune Anti-Tumor Drugs
Lingyi Biotech
Gene Therapy Drug Developer
Laekna Therapeutics
Innovative Drug Developer
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
BeOne Medicines Sees Positive Developments.
On November 19, BeOne Medicines announced that it had reached a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private, resolving patent litigation issues related to MSN's submission of a generic drug registration application for zanubrutinib in the United States.
According to the terms of the agreement, MSN will be unable to sell generic versions of Brukinsa before June 15, 2037, though this date may be moved earlier or later under certain customary circumstances. MSN did not contest the drug compound patent for Brukinsa in the lawsuit, which is set to expire in April 2034.
MicroCore Biotech Plans to Raise Funds Through Private Placement.
On November 20, MicroCore Biotech announced that the company plans to issue shares to specific investors to raise a total amount not exceeding 9.6 billion yuan. The net proceeds after deducting relevant issuance expenses will be used to invest in innovative drug research and development projects and replenish working capital.
As one of the first batch of companies listed on the STAR Market, Chipscreen Biosciences' stock price reached 125 yuan per share on its first day of listing, with the latest price at 22.97 yuan per share. So, can Chipscreen Biosciences produce a competitive pipeline through a private placement?
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Market Express
1) Zhejiang Jolly Pharmaceutical Co., Ltd. and Lingyi Biotech Sign Strategic Cooperation Framework Agreement
On November 20, Zhejiang Jolly Pharmaceutical Co., Ltd. announced that it had signed a "Strategic Cooperation Framework Agreement" with Lingyi Biotech. In terms of equity cooperation, Zhejiang Jolly Pharmaceutical will invest in Lingyi Biotech (A+ round) to become its second-largest shareholder. In terms of research and development cooperation, the two parties will jointly develop innovative drugs for neurological diseases such as Parkinson's disease and Alzheimer's disease.
2) Generic zanubrutinib must not be sold before 2037.
On November 19, BeOne Medicines announced that it had reached a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private, resolving patent litigation issues related to MSN's submission of a generic drug registration application for Brukinsa in the United States. According to the terms of the agreement, MSN will be unable to sell generic versions of Brukinsa before June 15, 2037, although this date may be moved earlier or later under certain customary circumstances. MSN did not contest the drug combination patent for Brukinsa in the litigation, which is set to expire in April 2034.
3) Laekna Therapeutics partners with Eli Lilly for clinical collaboration on a novel weight-loss drug
On November 20, Laekna Therapeutics announced that it had signed a clinical cooperation agreement with Eli Lilly to support and accelerate the global clinical development of LAE102 for the treatment of obesity. Eli Lilly will be responsible for conducting a Phase I study in the United States and covering the associated costs, while Laekna Therapeutics retains global rights to LAE102.
/ 02 /
Capital Information
1) MicroCore Biotech Plans to Raise No More Than 9.6 Billion Yuan Through Private Placement
On November 20, MicroCore Biotech announced that the company plans to issue stocks to specific investors to raise a total amount not exceeding 960 million yuan. The net proceeds after deducting relevant issuance expenses will be used to invest in innovative drug research and development projects and replenish working capital.
2) Biomayson Completes New Round of Financing Worth Hundreds of Millions
On November 20, Biomayson completed a new round of financing worth hundreds of millions of yuan. Biomayson, established in 2018, is dedicated to the research and development of next-generation specific immunotherapy for allergic and autoimmune diseases.
/ 03 /
Pharmaceutical News
1) Lilly's Orforglipron Capsules Receive Clinical Approval
On November 20, according to the CDE official website, Eli Lilly's Orforglipron capsule received clinical approval for the treatment of moderate to severe obstructive sleep apnea (OSA) in adult patients with obesity or overweight.
2) AbbVie's Atogepant Tablets Receive Clinical Approval
On November 20, according to the CDE official website, AbbVie's Atogepant Tablets received clinical approval and are proposed for use in the preventive treatment of menstrual migraines.
3) Tianchen Bio LP-003 Injection Receives Clinical Approval
On November 20, according to the CDE official website, Tianchen Biotech's LP-003 Injection received clinical approval and is proposed to initiate research for the treatment of food allergies.
4) Zai Lab's Efgartigimod Alfa Injection (Subcutaneous Injection) Receives Clinical Approval
On November 20, according to the CDE website, Zai Lab's Efgartigimod Alfa Injection (subcutaneous injection) received clinical approval and is planned to be studied for the treatment of ocular myasthenia gravis.
5) RAY1225 Injection by Zhongsheng Pharmaceutical Shows Positive Results in Phase II Weight Loss Clinical Trial
On November 20, Z众生药业 announced that the preliminary results of the Phase II clinical trial of RAY1225 injection for overweight/obese patients showed positive efficacy and good safety. The trial results were ideal and met the expected objectives.
6) ArriVent BioPharma's EGFR-TKI Approved for Marketing
On November 20, according to the NMPA website, Jiangsu Chentai Pharmaceutical's EGFR-TKI Zoritini tablets were approved for marketing. They are indicated as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, accompanied by central nervous system (CNS) metastases.
7)湃隆生物PRMT5 Inhibitor Completes First Patient Enrollment
On November 19,湃隆生物 announced that the first patient has been successfully enrolled in the Phase 1a/b study of its PRMT5 inhibitor GTA182 for MTAP-deleted advanced solid tumors.
/ 04 /
Instrument Tracking
1) Mindray's Syphilis Spirochete Antibody Assay Kit (Chemiluminescence Immunoassay) Receives Registration Approval
On November 20, according to the NMPA website, Mindray Biochemical's Treponema Pallidum Antibody Assay Kit (Chemiluminescence Immunoassay) obtained registration approval.
2) Lepu Diagnosis CYP2C19 Gene Mutation Detection Kit (PCR-Fluorescence Probe Method) Obtains Registration Approval
On November 20, according to the NMPA website, LePu Diagnostics' CYP2C19 Gene Mutation Detection Kit (PCR-Fluorescence Probe Method) obtained registration approval.
3) Libo Medicine Anti-Human Globulin (Anti-IgG+C3d) Detection Card (Column Agglutination Method) Obtains Registration Approval
On November 20, according to the NMPA website, Libo Pharmaceutical's Anti-Human Globulin (Anti-IgG+C3d) Detection Card (Column Agglutination Method) obtained registration approval.
/ 05 /
Overseas Pharmaceutical News
1) Bayer Obtains Japanese Rights for Cardiovascular Therapy
On November 19, Cytokinetics and Bayer announced that they have entered into a collaboration and licensing agreement for the exclusive development and commercialization of aficamten in Japan. The two parties will jointly develop and commercialize aficamten in Japan for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).
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