Legend Biotech Reports $152 Million Q3 Revenue from CAR-T Therapy Carvykti; Boyalife Pharma Chairman Penalized for Misleading Comments on Weight-Loss Drug
Legend Biotech
Tumor Cell Immunotherapy Developer
Johnson & Johnson
Medical Device R&D and Manufacturer
Weight-loss drug hype carries risks.
Recently, during the company's investor conference call, Yuan Jiandong stated that he personally tested the drug (BGM0504 injection), and his weight decreased from 91 kg to 76 kg (a reduction of 30 catties).
On October 17, BrightGene Bio-Medical Technology announced that due to the misleading statements made by Chairman Jianyu Yuan regarding the efficacy of the company's investigational product BGM0504 injection during a teleconference, the Jiangsu Securities Regulatory Bureau decided to issue a warning letter as an administrative regulatory measure.
Legend Biotech's CAR-T Therapy Continues to Shine with Overseas Revenue.
On October 17, Johnson & Johnson announced its Q3 financial report, with third-quarter sales reaching $21.35 billion, a year-on-year increase of 6.8%. Among these, the BCMA CAR-T therapy Carvykti, developed in collaboration with Legend Biotech, achieved sales of $152 million in Q3.
In the past day, what are the hot topics in the pharmaceutical market in China and abroad that are worth paying attention to? Let Amino take you through them.
/ 01 /
Industry Express
1) Chairman of BrightGene Bio-Medical Technology Receives Warning Letter from Jiangsu Securities Regulatory Bureau
On October 17, BrightGene Bio-Medical Technology announced that due to the misleading statements made by Chairman Jianyu Yuan regarding the efficacy of the company's investigational drug BGM0504 injection during a teleconference, the Jiangsu Securities Regulatory Bureau decided to issue a warning letter as an administrative regulatory measure.
2) Lukang Pharmaceutical's Net Profit in the First Three Quarters Increased by 110.21% Year-on-Year
On October 17, LuKang Pharmaceutical released its earnings快报, showing that in the first three quarters, the company achieved a total operating revenue of 4.732 billion yuan, an increase of 16.75% year-on-year; net profit attributable to shareholders of the parent company was 193 million yuan, an increase of 110.21% year-on-year. For this, Huadong Medicine paid 13 million US dollars as an upfront payment and 17 million US dollars as milestone payments, with the total agreement amount reaching 30 million US dollars.
3) Huadong Medicine Introduces ATGC's Botulinum Toxin for $30 Million
On October 17, Huadong Medicine announced that its wholly-owned subsidiary signed an exclusive product licensing agreement with ATGC, obtaining the global exclusive license for ATGC-110, an injectable solution containing botulinum toxin type A owned by ATGC.
4) BioRay Biotech's General Manager Pledges Not to Reduce Company Shares in the Next Six Months
On October 17, Baik Biotech announced that Kong Wei, a shareholder holding more than 5% of the company's shares, director, and general manager, voluntarily committed not to reduce his entire shareholding in the company in any manner within the next six months from the date of issuance of the commitment letter. As of the date of the announcement, Kong Wei holds 25.3% of the company's shares.
5) Resignation of Chairman of Peking University Medicine
On October 16, Peking University Health Science Center announced that the board of directors had recently received a written resignation report from the company's chairman, Song Jinsong. Song Jinsong applied to resign from his positions as director and chairman of the company for personal reasons, and will no longer hold any position in the company.
6) Hengrui PD-1 Combination Therapy for Liver Cancer Indication Licensed Overseas
On October 17, Hengrui Medicine announced that it had reached a cooperation agreement with Elevar Therapeutics. Elevar will obtain the exclusive rights to develop and commercialize camrelizumab in combination with apatinib for the treatment of hepatocellular carcinoma globally, excluding Greater China and South Korea.
7) Ascentage Pharma and AstraZeneca Reach Clinical Collaboration
On October 16, Ascentage Pharma announced that it had reached a clinical collaboration agreement with AstraZeneca. The two parties will jointly conduct a pivotal Phase 3 clinical study of the Bcl-2 inhibitor APG-2575 in combination with AstraZeneca's BTK inhibitor Calquence.
/ 02 /
Pharmaceutical News
1) NewView Bio/Shenzhen Small Molecule Innovative Drug R&D Center ND-003 Tablets Approved for Clinical Trials
On October 17, according to the CDE, ND-003 tablets developed by Xinyue Bio/Shenzhen Small Molecule New Drug Innovation Center were approved for clinical trials for the treatment of advanced solid tumors.
2) Elpiscience ES104 Approved for Clinical Trials
On October 17, according to the announcement by CDE, Elpiscienc ES104 has been approved for clinical trials, intended to be used in combination with paclitaxel for locally advanced or metastatic solid tumors.
3) HaiRong Pharmaceuticals HR1405-01 Injection Approved for Clinical Trials
On October 17, according to the CDE official website, Huirong Pharmaceutical's HR1405-01 injection was approved for clinical trials, intended for antipyretic treatment of fever in adult patients.
4) Liraglutide, a Fosun Pharma R&D product, is in Phase III clinical trials.
On October 17, Fosun Pharma stated on an interactive platform that its investigational product, liraglutide (intended for diabetes and obesity indications), is currently in Phase III clinical trials in China.
5) Lepu Medical Subsidiary’s Semi-Automatic External Defibrillator Receives Registration Approval
On October 17, LePu Medical announced that the semi-automatic external defibrillator independently developed by its subsidiary, Shenzhen Kerui Kang Industrial Co., Ltd., has officially received registration approval from the National Medical Products Administration (NMPA).
6) Clinical Trial Application for China Biologic Products' Weight Loss Drug in Development Accepted
On October 16, China Biologic Products Holdings announced that the investigational weight-loss drug GMA106 (GIPR antagonist/GLP-1 agonist) had submitted a Phase Ib/II clinical trial application to the CDE and was accepted for the treatment of adult patients with overweight and obesity.
7) Xingqi Eye Medicine Obtains Sodium Hyaluronate Eye Drops Drug Registration Certificate
On October 17, Xingqi Eye Drops announced that its Sodium Hyaluronate Eye Drops had been approved for marketing to treat dry eye syndrome and alleviate dry eye symptoms.
8) Huahai Pharmaceutical's Subsidiary HB0034 Injection Granted FDA Orphan Drug Designation in the U.S.
On October 17, Huahai Pharmaceutical announced that HB0034 Injection (anti-IL-36R monoclonal antibody), a product of its subsidiary Huaotai, received orphan drug designation from the FDA for the treatment of Generalized Pustular Psoriasis (GPP).
9) MicuRx Pharmaceuticals' MRX-5 Receives Approval for Phase I Clinical Trial in Australia
On October 17, MicuRx Pharmaceuticals announced that MRX-5, a novel benzoxaborole antibiotic independently developed by the company, has been approved for Phase I clinical trials in Australia. It is intended for the treatment of mycobacterial infections, particularly those caused by non-tuberculous mycobacteria.
10) Aosaikang Subsidiary's Anti-CLDN18.2 Monoclonal Antibody Approved for Pivotal Phase 3 Clinical Trial
On October 17, AskGene, a subsidiary of Aosaikang, announced that it had received approval from the CDE to conduct a Phase 3 clinical study to evaluate the efficacy and safety of targeted CLDN18.2 monoclonal antibody ASKB589 injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor as first-line treatment for patients with CLDN18.2-positive unresectable locally advanced, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma.
/ 03 /
Overseas News
1) Johnson & Johnson's Q3 adjusted sales reached $21.35 billion
On October 17, Johnson & Johnson announced its Q3 financial report, with third-quarter sales reaching $21.35 billion, a year-on-year increase of 6.8%. Among this, the BCMA CAR-T therapy Carvykti, developed in collaboration with Legend Biotech, achieved sales of $152 million in Q3.
2) MSD's Keytruda Approved for New Indication
On October 16, Merck announced that the FDA has approved the PD-1 inhibitor Keytruda for the treatment of patients with resectable (tumor ≥4 cm or lymph node-positive) non-small cell lung cancer (NSCLC), in combination with platinum-containing chemotherapy as neoadjuvant therapy before surgery, and as monotherapy adjuvant treatment after surgery.
3) Novo Nordisk Acquires Ocedurenone for $1.3 Billion
On October 16, Novo Nordisk and Henry Medicines jointly announced that Novo Nordisk acquired Ocedurenone from Henry Medicines for up to 1.3 billion US dollars. This acquisition is contingent upon Ocedurenone receiving relevant regulatory approvals and other customary conditions, and is expected to be completed before the end of 2023.
Text / Fang Taozhi
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