China Approves 14th Domestic PD-(L)1 Inhibitor; AbbVie Strengthens Autoimmune Portfolio with Celsius Therapeutics Acquisition
Elpiscience
Innovative R&D Provider of Tumor Immunotherapy
TransThera
Small Molecule Innovative Drug Research, Development, and Manufacturing
Phrontline Biopharma
Antibody-Drug Conjugate (ADC) Developer
IASO Biotechnology
Cancer Treatment New Drug Developer
Maxvax
Innovative Vaccine and Novel Adjuvant Research, Development, and Production
New Competitor Joins the Crowded Track.
On June 28, according to the official website of NMPA, Junshi Biosciences' PD-1 inhibitor Envafolimab was approved for marketing. Its indication is for patients with recurrent or metastatic cervical cancer who have failed at least one line of platinum-based chemotherapy and are PD-L1 positive.
As of now, Envafolimab has become the 14th domestically produced PD-(L)1 monoclonal antibody drug approved for marketing in China.
AbbVie continues to expand its presence in the autoimmune field.
On June 27, AbbVie announced the acquisition of Celsius Therapeutics for $250 million. The core product of Celsius Therapeutics, CEL383, is a potential "first-in-class" TREM1-targeting antibody, primarily used for treating inflammatory bowel disease.
Multiple Pharmaceutical Companies Apply for HKEX IPO
On June 27, according to the Hong Kong Stock Exchange disclosure, Elpiscience and TransThera have submitted their IPO applications. Will they successfully go public?
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 /
Capital Information
1) Elpiscience Applies for HKEX IPO
On June 27, according to HKEX's Disclosure Easy, Elpiscience submitted its IPO application. Elpiscience, established in 2017, is an enterprise dedicated to developing innovative oncology drugs.
2) TransThera Submits Application for IPO on the Hong Kong Stock Exchange
On June 27, according to Hong Kong Exchanges and Clearing Limited (HKEX) Disclosure Easy, TransThera submitted its IPO application. TransThera, established in 2014, focuses on the discovery and development of innovative small molecule therapies for oncology, inflammation, and cardiometabolic diseases.
3) Phrontline Biopharma Completes Over 100 Million Yuan Pre-A Financing
On June 27, Phrontline Biopharma announced the completion of a Pre-A round of financing exceeding 100 million yuan. Reportedly, the funds raised will be used to increase R&D investment, accelerate the progress of multiple preclinical pipelines, and upgrade its proprietary technology platform.
/ 02 /
Pharmaceutical News
1) IASO Bio's RD118 Injection Approved for Clinical Trials
On June 28, according to the CDE official website, IASO Bio's RD118 Injection has been approved for clinical trials, aiming to conduct research on the treatment of relapsed/refractory multiple myeloma (RRMM).
2) IASO Bio's U87 Injection Approved for Clinical Trials
On June 28, according to the CDE official website, U87 Injection from Youkadi Bio has been approved for clinical trials, aiming to conduct research on the treatment of Trop2-positive advanced malignant tumors.
3) Maikang Bio's Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) Approved for Clinical Trials
On June 28, according to the CDE website, Maikang Bio's recombinant Respiratory Syncytial Virus vaccine (CHO cell) was approved for clinical trials, intended for the prevention of lower respiratory tract diseases caused by the Respiratory Syncytial Virus.
4) Yond Pharma's Intravenous Human Immunoglobulin (pH4) Approved for Clinical Use
On June 28, according to the CDE official website, Yuanda Shuyang's intravenous human immunoglobulin (pH4) was approved for clinical trials, intended for use in primary immune thrombocytopenia.
5) Luoxin Pharmaceutical's LX22001 for injection approved for clinical trials
On June 28, according to the CDE official website, Luoxin Pharmaceutical Co., Ltd.'s injectable LX22001 was approved for clinical trials, aiming to conduct research on the treatment of peptic ulcer bleeding.
6) Elpiscience's Citrate Sildenafil Injection Approved for Clinical Trials
On June 28, according to the CDE website, Elpiscience's Citrate Sildenafil Injection has been approved for clinical trials. It is intended for the treatment of adult pulmonary arterial hypertension to improve exercise capacity and delay clinical deterioration.
7) Precision Bio's pCAR-19B Autologous Cell Infusion Formulation Granted Priority Review
On June 27, according to the CDE website, Precision Biologics' pCAR-19B autologous cell infusion preparation, Prucabartcel Injection, is proposed for priority review. The indication is for the treatment of patients aged 3 to 21 with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia.
8) CSPC's PD-1 Approved for Marketing
On June 28, according to the NMPA website, Junshi Biosciences, a subsidiary of CSPC Group, received approval for the market launch of its PD-1 inhibitor Envafolimab. The indication is for patients with recurrent or metastatic cervical cancer who have failed at least one line of platinum-based chemotherapy and are PD-L1 positive.
9) BeiGene's Tislelizumab Receives Approval for 14th Indication
On June 28, according to the NMPA website, BeiGene's tislelizumab received approval for its 14th indication, specifically for use in combination with etoposide and platinum-based chemotherapy as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).
10) Bio-Thera's Antithrombotic Drug Bevibapide Approved for Marketing
On June 28, according to the NMPA website, Bio-Thera Solutions' Bevibapeptide was approved for marketing in China, for antithrombotic therapy during the perioperative period of PCI.
11) Bioray Biopharma's Tocilizumab Approved for Marketing
On June 28, according to the NMPA website, BriBiopharm's Tocilizumab was approved for marketing in China, indicated for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.
12) And誉 Pharma Announces Latest Research Results of FGFR4 Inhibitor
On June 28, Abbisko Therapeutics announced that it presented the latest clinical trial data of its self-developed highly selective small molecule FGFR4 inhibitor, Epatogotinib, in combination with Atezolizumab for the treatment of advanced hepatocellular carcinoma at the 2024 ESMO-GI conference. The cohort combining Epatogotinib 220mg BID with Atezolizumab demonstrated remarkable efficacy in FGF19-overexpressing hepatocellular carcinoma patients, achieving an ORR of 50%.
13) Staidson's Injectable STSP-0601 Receives U.S. FDA Orphan Drug Designation
On June 28, Staidson announced that STSP-0601, indicated for the treatment of Hemophilia A and Hemophilia B, has been granted Orphan Drug Designation by the US FDA.
/ 03 /
Instrument Tracking
1) Weitai Medical Coronary Indentation Balloon Dilation Catheter Not Approved
On June 28, according to the NMPA website, ForTai Medical's coronary indentation balloon dilation catheter was not approved.
2) Xinyue Medical's Non-Absorbable Suture Anchor Not Approved
On June 28, according to the NMPA website, New Leap Medical's non-absorbable suture anchor was not approved.
3) Johnson & Johnson’s Disposable Electric Endoscopic Linear Cutter and Staple Cartridge Registration Review Terminated
On June 28, according to the NMPA website, Johnson & Johnson's disposable electric endoscopic linear cutting stapler and cartridge have ceased registration review.
4) Boming Medical X-ray Computed Tomography Equipment Termination of Registration Review
On June 28, according to the NMPA website, Bowei Medical's X-ray computed tomography equipment registration review was terminated.
/ 04 /
Overseas Pharma News
1) AbbVie Reaches $250 Million Acquisition Agreement
On June 27, AbbVie announced the acquisition of Celsius Therapeutics for $250 million. The core pipeline of Celsius Therapeutics, CEL383, is a potential "first-in-class" TREM1-targeting antibody for the treatment of inflammatory bowel disease.
Text / Huang Kai
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