Goby Asia Healthcare Weekly 8/13
Highlights of the Week
Japanese and Chinese healthcare companies are dominating the Asian capital market. Goby News published an overview of the current Top 25 Healthcare Companies in the Asia-Pacific, ranked by market cap. To read the Goby exclusive article, click here.
Gracell Biotechnologies (Nasdaq; GRCL) raised $100 mil through an over-subscribed PIPE transaction led by Vivo Capital and joined by leading healthcare investors including Adage Capital, Exome Asset Management, Janus Henderson Investors, Logos Capital, OrbiMed, Pivotal Life Sciences, RA Capital Management, and TCGX. Gracell is the third best performer among Chinese Biotech companies, returning 12.3% last week and 67% YTD. Read more here.
Neurophth Therapeutics, a Chinese gene therapy company for ophthalmic diseases, announced the closing of nearly US$95 million in Series C+ financing. The round was co-led by Yangtze River-CMB International Industry Fund, Wuhan Optical Valley Financial Holding Group, Wuhan Hi-Tech Holding Group, Hubei KTLC and Guangzhou Jinkong Fund. Raised funds will go towards R&D. Read more here.
Jacobio Pharma received breakthrough therapy designation from the China CDE for Glecirasib, a KRAS G12C inhibitor for the treatment of pancreatic cancer. Glecirasib's pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. Read more here.
The top 3 gainers of Chinese biotech companies for the week are Chengdu Shengnuo Biotech, Ascentage, and Gracell, returning 47.4%, 23.4% and 12.3%, respectively. The bottom 3 performers of Chinese biotech companies for the week are Keymed, Innocare, and HUTCHMED, declining 13.9%, 12.2%, and 10.8%, respectively. Shengnuo Biotech issued a statement that the company has no undisclosed materials information that should be disclosed. The ongoing anti-corruption campaign in healthcare in China caused panic in investors. The roughly 70 Chinese biotech companies Goby tracks lost 3.3% on average for the week. Going forward, Goby capital market coverage will alternate between healthcare stocks in Asia and Chinese biotech stocks.
Antengene?and Hansoh Pharmaceutical entered a collaboration agreement for XPOVIO, an XPO1-inhibitor to treat multiple myeloma. Hansoh Pharma will be exclusively responsible for the commercialization of XPOVIO in China. In exchange, Antengene will receive RMB200 million in upfront payments and up to RMB525 million in potential milestones. Read more here.
Over the first half of 2023, Chinese medical exports dropped by 26.1% year-on-year, attributed to softening external demand affecting the Chinese medical industry. The China Chamber of Commerce for Import and Export of Medicines and Health Products predicts that the full year of 2023 will see a 15% drop year-on-year of medical exports, as the demand from COVID supplies falls. Read more here.
President Biden signed an executive order intended to curb U.S. investment dollars and technology knowledge from flowing into select Chinese firms identified as potential contributors to the Chinese military. Notably, the biotech industry is excluded! Goby conducted an informal poll on LinkedIn here.?More than 50% said the executive order is a relief, although the number of the poll responders (10) is small. Read more here.
Thanks to the latest revision of listing rules coming out of Beijing, Hong Kong’s stock exchange will no longer require companies to outline China-related business risks in listing applications. Read more here.
CanSino Biologics and AstraZeneca entered into a strategic agreement for CanSino to support AstraZeneca's mRNA vaccine programs with contract development and manufacturing services. Financial details were not disclosed. Read more here.
Insilico Medicine, a Hong-Kong based biotech company that uses AI to power drug discovery, has filed for a Hong Kong IPO, pivoting from its previous plan to list?on the New York Stock Exchange. The Company hopes to raise US$200 million. Read more here and here.
Duality Biologics has expanded its collaboration with?BioNTech SE to develop, manufacture and commercialize a third ADC candidate to treat solid tumors, DB-1305, outside of China. BioNTech will hold commercial rights globally excluding Greater China, while DualityBio will retain commercial rights for Greater China and receive an undisclosed upfront payment, potential milestones, and royalties. Read more here.
Greater China News
Business Development
Arcutis Biotherapeutics?and Hangzhou Zhongmei Huadong Pharmaceutical entered a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast, a PDE4 inhibitor to treat dermatological conditions. Huadong will receive an exclusive license for roflumilast in Greater China and regions in Southeast Asia; Arcutis will receive $30 million upfront and potential milestones. Read more here.
Corium and Lotus Pharmaceutical?entered an exclusive Collaboration and License Agreement for ADLARITY? in ten markets across Asia. ADLARITY? is approved by the U.S. FDA as the first and only once-weekly patch to treat Alzheimer's dementia. Read more here.
GenScript Biotech?and?T-Maximum Biotech?entered a strategic collaboration agreement to further T-Maximum's CAR-T cell therapy development and deliver products to market within the next five years, using GenScript's CRISPR nucleic acid reagents. Read more here.
Clinical & Regulatory
Huidagene Therapeutics?received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for HG004, a one-time, direct-to-RPE treatment of inherited retinal disease caused by mutations in the RPE65 gene. Receiving this designation allows for an expedited six-month priority review voucher (PRV); this accelerated regulatory review can be worth substantial economic value to companies. Read more here.
Asieris announced that its Phase III bridging clinical trial of Hexvix? for bladder cancer diagnosis met the primary endpoint; the results will be presented at upcoming academic conferences. Read more here.
AffaMed Therapeutics announced that its partner?Vistagen Therapeutics?reported positive top-line results from its Phase 3 PALISADE-2 trial of fasedienol nasal spray to treat social anxiety disorder, demonstrating a statistically significant difference compared to placebo. Read more here.
Lynk Pharmaceuticals announced positive topline data from a Phase II clinical trial of LNK01001 to treat atopic dermatitis, showing significant improvement in patients after 12 weeks of treatment. Read more here.
Ascentage Pharma?received clearance from the U.S. FDA to initiate a global registrational Phase III study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma. Read more here.
Oricell Therapeutics received IND clearance in China for its OriCAR-017 CAR-T therapy, targeting GPRC5D to treat relapsed or refractory multiple myeloma. Read more here.
BioCity?received IND clearance from the U.S. FDA for BC3448, its first-in-class CD3-based bispecific antibody that recruits T cells to tumors cells with high EGFR expression resulting in T cell-driven tumor cell killing. Read more here.
Venus Medtech Inc. received an Investigational Device Exemption from the U.S. FDA for its Venus P-Valve cardiovascular device, allowing the company to initiate clinical trials in the U.S. to support the Pre-Market Approval. Read more here.
China Pharma Holdings announced its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology received drug supplementary application approval from the Chinese NMPA for its candesartan tablets, an angiotensin II antagonist to treat primary hypertension. Read more here.
Baird Medical submitted a 510(k) premarket notification to the U.S. FDA for its Disposable Microwave Ablation Needle and MWA System for the treatment of soft tissue microwave ablation. Read more here.
People
Harbour BioMed?appointed Dr. Albert R. Collinson as independent non-executive director. Read more here.
Financial Results
I-Mab?will release its financial results for the first half of 2023 on August 17, 2023. Read more here.?
Everest Medicines?will release its financial results for the first half of 2023 on August 24, 2023. Read more here.
Greater Asia News
Japan
Astellas Pharma and?Poseida Therapeutics?announced a strategic investment to help advance Poseida's cancer cell therapy pipelines. Astellas will invest $50 million to acquire approximately 8.8% of Poseida, a right of exclusive negotiation and first refusal for a potential partnering of P-MUC1C-ALLO1 (an allogeneic CAR-T cell therapy for solid tumors), and the right to designate an observer on Poseida's Board of Directors and scientific advisory board. Read more here.
Meiji Seika Pharma Co. announced positive results in its Phase II study of ME3183, a novel PDE4 inhibitor for the treatment of plaque psoriasis, meeting its primary endpoint of the proportion of subjects achieving 75% improvement in Psoriasis Area Severity Index (PASI). Read more here.
Sosei Heptares and?Cancer Research UK?dosed the first patient in a Phase I/IIa clinical trial of HTL0039732, an orally-available small molecule cancer immunotherapy drug for advanced solid tumors. Read more here.
Astellas?announced plans to open a new life sciences facility in Cambridge, Massachusetts. Read more here.
South Korea
SK bioscience?announced its decision to make an equity investment in Novavax, a protein-based vaccines company with a novel Matrix-M? adjuvant, securing 6.5 million shares of common stock through a private placement. Read more here.
Vatech?announced that its oral health products will be distributed by Henry Schein to increase availability at dental clinics in North America. Read more here.
Lemonex?received IND clearance from South Korea's MFDS for its mRNA vaccine LEM-mR203 with DegradaBALL, its nano-drug delivery technology. Read more here.
India
Dr. Reddy's Labs?launched Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S. market, approved by the U.S. FDA. Read more here.
Sathgen Therapeutics completed dosing of the first two healthy volunteer cohorts in a Phase 1 clinical trial for MSP008-22 to combat viral infections. Read more here.
Voxelgrids?launched an advanced and affordable MRI scanner that costs around USD 400,000 compared to the price range of USD 670,000 to USD 1.2 million for conventional 1.5T whole body scanners. Read more here.?
Singapore
Sunbird Bio?completed a merger with?Glympse Bio?to accelerate development of the companies’ protein-based diagnostic platforms. Financial details are undisclosed. The new combined Sunbird Bio will have U.S. headquarters in Cambridge, Mass., with operational headquarters in Singapore. Read more here.
ALR Technologies announced plans to launch the GluCurve Pet CGM in Canada during Q3 2023 with a direct to veterinarian clinic sales model. Read more here.
Conferences
Click here to view our calendar of Upcoming Conferences.
Including:
August 14-16, 2023: Stifel Biotech Summer Summit (Newport, RI)
August 17, 2023: International Conference on Orphan Drugs and Rare Diseases (Virtual)
August 26-27, 2023: Novel Vaccine R&D Summit (Beijing, China)
August 29, 2023: Annual Oligonucleotide CMC and Analytical Development Summit?(Boston, MA)
August 30-Sept 1, 2023: CPHI Korea (Seoul, South Korea)
Sept 6-7, 2023: Citi 18th Annual BioPharma Conference (Boston, MA)
Sept 6-8, 2023: Wells Fargo Healthcare Conference (Boston, MA)
Sept 9, 2023: ERS International Congress (Milan, Italy)
Sept 13-16, 2023: The International Biotech Convention (Hong Kong)
Sept 14-15, 2023: Second Annual ADC China Forum (Suzhou, China)
Oct 20-24, 2023: China Conference on Rare Diseases (Beijing, China)
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