Lilly's Weight-Loss Drug Approved in China; Pilot Therapeutics Sells CDK7 Inhibitor Rights
Apeiron
Pharmaceutical R&D Developer
Exscientia
Developer of Artificial Intelligence (AI)-Driven Drug Discovery Technology
Delova Biotech
Developer of Improved New Drugs
China's weight-loss drug market adds another strong competitor.
On July 19, Eli Lilly announced that its tirzepatide injection for weight loss had been approved by the regulatory authority for marketing in China. It is suitable for long-term weight management in adults with a body mass index (BMI) meeting the following conditions, in addition to diet control and increased exercise: BMI ≥ 28 kg/m² (obesity), or BMI ≥ 24 kg/m² (overweight) accompanied by at least one weight-related complication.
Biotech Companies Sell Pipeline Rights to Survive.
On July 19, Apeiron Therapeutics announced the sale of 50% of its rights to GTAEXS617, a highly selective oral CDK7 inhibitor, to Exscientia.
According to the agreement, Apeiron will receive a deal worth $30 million, including $10 million in cash, $10 million in Exscientia shares, and high single-digit royalties from project out-licensing, with a potential value exceeding $100 million.
China's drug regulator suspends the import, operation, and use of two artificial joints from Italian company Samo.
On July 19, the National Medical Products Administration (NMPA) issued an announcement stating that inspections revealed that Italy's Samo Company failed to effectively identify China's regulatory requirements and had errors in product technical specifications related to dimensional parameters. The comprehensive evaluation concluded that the company does not comply with China’s "Good Manufacturing Practice for Medical Devices" and the "Annex to the Good Manufacturing Practice for Medical Devices – Implantable Medical Devices." Effective immediately, the importation, distribution, and use of Samo Company's artificial knee joint system and non-cemented artificial hip joint system will be suspended.
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) NMPA Suspends Import, Operation and Use of Two Artificial Joints from Italian Company Samo
On July 19, the National Medical Products Administration (NMPA) announced that inspections revealed that Italy's Samo Company failed to effectively identify China's regulatory requirements and had errors in the dimensional parameters of product technical specifications. The comprehensive evaluation concluded that the company did not comply with China’s "Medical Device Production Quality Management Regulations" and the "Annex to the Medical Device Production Quality Management Regulations for Implantable Medical Devices." Effective immediately, the importation, operation, and use of Samo Company's artificial knee joint system and non-cemented artificial hip joint system will be suspended.
2) Hainan Shuangcheng Pharmaceuticals Co., Ltd. Plans to Sign Technical Service Contract with Delova Biotech
On July 19, Hainan Shuangcheng Pharmaceuticals Co., Ltd. announced that the company plans to sign a "Technical Service Contract" with its related party Delova Biotech. Delova Biotech has entrusted the company to conduct technical research on the QP002 gel project at the company’s premises and will pay a technical service fee and remuneration of RMB 4.8 million. The company has accepted the commission to carry out technical service work for this project.
3) Apeiron Therapeutics Sells CDK7 Inhibitor Rights
On July 19, Apeiron Therapeutics announced the sale of 50% of its rights to GTAEXS617, a highly selective oral CDK7 inhibitor, to Exscientia. Under the agreement, Apeiron will receive $30 million in total consideration, including $10 million in cash, $10 million worth of Exscientia stock, and high single-digit royalties from future out-licensing agreements, with a potential value exceeding $100 million.
/ 02 /
Capital Information
1) Daring Bioscience Completes $35 Million Series A+ Financing
On July 19, nucleic acid drug development biotech Daring Biotechnology announced the successful completion of a $35 million Series A+ financing round.
/ 03 /
Pharmaceutical News
1) Zhonghui Yuantong Quadrivalent Influenza Virus Subunit Vaccine Approved for Clinical Trials
On July 19, according to the CDE official website, Zhonghui Yuantong's quadrivalent influenza virus subunit vaccine was approved for clinical trials, intended for use in preventing influenza caused by vaccine-related strains of the influenza virus in individuals aged 65 years and above.
2) Xinqi Pharmaceutical Azithromycin Eye Drops Approved for Clinical Trials
On July 19, according to the CDE official website, Xinqi Medicine's azithromycin eye drops were approved for clinical trials, intended for the treatment of bacterial conjunctivitis caused by susceptible strains of Corynebacterium group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.
3) Chipscreen Biosciences' Ciglitazone Sodium in combination with Metformin approved for Type 2 Diabetes indication
On July 19, MicroCore Bio announced that a new indication for Ciglitazone Sodium Tablets was approved: "For use in combination with Metformin Hydrochloride: When blood glucose control is inadequate with Metformin Hydrochloride alone, this product can be used in combination with Metformin Hydrochloride to improve blood glucose control in adult patients with type 2 diabetes, in conjunction with diet and exercise."
4) Biotech BAT2206 Injection Marketing Authorization Application Accepted by US FDA and European EMA
On July 19, Bio-Thera Solutions announced that it had submitted a Biologics License Application (BLA) for BAT2206 (Ustekinumab) Injection to the U.S. FDA and European EMA, and recently received notification of acceptance from both the U.S. FDA and European EMA.
5) Lilly's Tirzepatide Weight Loss Indication Approved
On July 19, Eli Lilly announced that the weight loss indication for tirzepatide injection has been approved for marketing by the regulatory authority in China. It is suitable for long-term weight management in adults with a body mass index (BMI) meeting the following criteria, in addition to dietary control and increased physical activity: ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) accompanied by at least one weight-related comorbidity.
6) UCB's IL-17A/IL-17F Monoclonal Antibody Approved for Marketing
On July 19, the NMPA website showed that UCB's IL-17A/IL-17F monoclonal antibody bimekizumab was approved for marketing.
/ 04 /
Instrument Tracking
1) Jiaqi Biomedical Microguidewire Approved for Marketing
On July 19, the NMPA website showed that the micro guidewire from JiaChi Bio has been approved for marketing.
2) Lepu Medical's Single-Use Drug-Coated Central Venous Catheter Approved for Marketing
On July 19, the NMPA website showed that the LePu Medical’s disposable drug-coated central venous catheter was approved for marketing.
3) Crown Boat Technology's semiconductor laser hair removal device approved for marketing
On July 19, the NMPA website showed that Guanzhou Technology's semiconductor laser hair removal device was approved for marketing.
4) Kondi Taikang Neurovascular Support Catheter System Approved for Marketing
On July 19, the NMPA website showed that Canditaike's neurovascular support catheter system was approved for marketing.
/ 05 /
Overseas Pharmaceutical News
1) Phase III Study of Tivozanib Combined with Opdivo for Renal Cell Carcinoma Fails
On July 18, AVEO Oncology announced that the Phase III TiNivo-2 study of Tivozanib in combination with Nivolumab for second-line/third-line treatment of patients with advanced metastatic renal cell carcinoma (RCC) did not meet the primary endpoint of progression-free survival (PFS).
Text / Huang Kai
PS: Welcome to scan the QR code below to add the WeChat ID of Anji Jun for communication.
