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BioWorld - Friday, September 22, 2023
Home » Topics » Asia-Pacific » China

China
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Chinese flag and pills

Kickoffs for China drug trials: Leads, Hanchorbio, Transcenta, Everest

Aug. 8, 2023
By Marian (YoonJee) Chu
No Comments
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
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Doctor examining patient's hand

China’s NMPA accepts Luye’s NDA for long-acting rotigotine to treat Parkinson's disease

Aug. 8, 2023
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.
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HKEX on phone, digital stock chart

Biologic cancer drug developer Sunho targets HK IPO

Aug. 8, 2023
By Marian (YoonJee) Chu
No Comments
On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).
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CAR T cells attacking cancer cell

Chinese CAR T-maker Gracell raises $150M in private financing

Aug. 8, 2023
By Marian (YoonJee) Chu
No Comments
Gracell Biotechnologies Inc. stands to gain up to $150 million from an assorted bouquet of private U.S. health care investors to lay a solid foundation for clinical trials of its leading dual-targeting CAR T-cell candidate, GC-012F, and provide a cash runway into the second half of 2026.
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HKEX on phone, digital stock chart

Biologic cancer drug developer Sunho targets HK IPO

Aug. 4, 2023
By Marian (YoonJee) Chu
No Comments
On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).
Read More
Genesis Medtech's Artisential aparoscopic surgical device

Genesis has promising start in China with laparoscopic surgical device clearance

Aug. 3, 2023
By Doris Yu
No Comments
Genesis Medtech Group received marketing approval from China’s National Medical Products Administration for its laparoscopic surgical device called Artisential, which helps surgeons in precision surgery. The approval not only adds another market in which the device is available but will allow Genesis to expand its reach in China.
Read More
Doctor examining patient's hand

China’s NMPA accepts Luye’s NDA for long-acting rotigotine to treat Parkinson's disease

Aug. 2, 2023
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease. The microsphere formulation delivers the dopamine agonist in a weekly injection. If approved, LY-03003 would be the first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease (PD). The drug is also being developed in parallel in the U.S. and Japan.
Read More
Chinese flag and pills

Kickoffs for China drug trials: Leads, Hanchorbio, Transcenta, Everest

Aug. 2, 2023
By Marian (YoonJee) Chu
No Comments
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
Read More
Adlai Nortye

Aggressive licensor, cancer-focused Adlai Nortye files for US IPO

Aug. 1, 2023
By Marian (YoonJee) Chu
No Comments
Hangzhou and New Jersey-based cancer biotech Adlai Nortye Ltd. – formerly Hangzhou Nuotai Pharmaceutical Co. Ltd. – announced plans to list on Nasdaq with its U.S. IPO filed on July 27.
Read More
Surgeons using Tirobot Recon to conduct total knee replacement

Tinavi’s surgical robot is approved for knee replacement in China

July 27, 2023
By Doris Yu
No Comments
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
Read More
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