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BioWorld - Monday, December 15, 2025
Home » Topics » Asia-Pacific » Australia

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Illustration of cancer cells entering the blood stream
Cancer

Bryet’s ML-016 gains clearance for first-in-human trial

Oct. 8, 2025
No Comments
Bryet US Inc. has received Australian Human Research Ethics Committee (HREC) approval for its first-in-human study of ML-016 for patients with advanced cancer with lung and/or liver involvement. Enrollment in the phase I/II trial will begin early next year.
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Global vaccine illustration

So far, ACIP vaccine recommendations in line with the world

Oct. 2, 2025
By Mari Serebrov
No Comments
While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.
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Stock chart, upward arrow

Genentech $569M deal lifts Starpharma stock 73%

Sep. 23, 2025
By Tamra Sami
No Comments
Starpharma Holdings Ltd.’s stock shot up 73% on the news that it is outlicensing its dendrimer enhanced product drug delivery technology to Roche Holding AG subsidiary Genentech Inc. in a deal worth more than $569 million.
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Syringe in front of Moderna logo

Australia bets on mRNA as Moderna builds regional hub

Sep. 23, 2025
By Tamra Sami
No Comments
While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.
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Stock chart, upward arrow

Genentech $569M deal lifts Starpharma stock 73%

Sep. 22, 2025
By Tamra Sami
No Comments
Starpharma Holdings Ltd.’s stock shot up 73% on the news that it is outlicensing its dendrimer enhanced product drug delivery technology to Roche Holding AG subsidiary Genentech Inc. in a deal worth more than $569 million.
Read More
Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 18, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
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Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Read More
Illustration of adipose tissue under the skin
Endocrine/metabolic

Rona Therapeutics seeks IND clearance for RN-3161 for obesity

Sep. 16, 2025
No Comments
Rona Therapeutics Co. Ltd. has announced an IND filing with the Australian Human Research Ethics Committee (HREC) for RN-3161 for obesity. RN-3161, a novel siRNA developed through Rona’s proprietary GAIA platform, targets INHBE to reduce fat while preserving lean mass.
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Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 10, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Read More
Cancer

Pharmaengine’s PEP-08 gains trial clearances for solid tumors

Sep. 10, 2025
No Comments

Xtalpi Inc. has announced regulatory clearances in Australia and Taiwan for phase I trials of PEP-08, a next-generation PRMT5 inhibitor candidate developed under its AI drug discovery collaboration with Pharmaengine Inc., for solid tumors. This milestone triggered a payment to Xtalpi under the partnership agreement.


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