Chinese biotech begins downsizing; Hengrui requests freezing BeyongSpring assets; US IPO performance mixed

Highlights of the Week

Downsizing of Chinese biotech companies has begun.?Rumor has it that Reistone Biopharma (Private, HQ in Shanghai) has started downsizing, and its controlling shareholder Hengrui Pharma may takeover the company. There are rumors of other Chinese biotech companies downsizing as well.? Read more?here.?

In an unusual move, Hengrui Pharma (SHA: 600276) requested freezing the assets of 200 mil RMB of a Chinese subsidiary of BeyondSpring (Nasdaq: BYSI) in a Beijing court filing.?This amount is equal to the upfront payment Hengrui paid to Beyond Spring in a licensing transaction in 2021 (read more?here).

Mixed US IPO performance:?Neumora Therapeutics (NMRA), a company focused on brain diseases, raised $250 mil in gross proceeds and closed the week at $16.25,?down 4.4%?from its IPO offer price of $17. RayzeBio, a vertically integrated radiopharmaceutical therapeutics company, raised $311 mil in gross proceeds and closed the week at $24,?33.4% higher?than its IPO offer price of $18. Read more?here.

Insilico Medicine?(Private, HQ in Hong Kong) and?Exelixis?(Nasdaq: EXEL) entered into an exclusive license agreement granting Exelixis global rights to develop and commercialize ISM3091, a potentially best-in-class small molecule inhibitor of USP1, a synthetic lethal target in the context of BRCA-mutated tumors. Insilico will receive an?upfront payment of $80 million; development, commercial, and sales-based milestone payments; and tiered royalties on net sales. Read more?here.

LIB Therapeutics (Private; HQ in Cincinnati, USA) and Hasten Biopharma (Private, HQ in Shanghai) entered into an agreement?granting Hasten the rights to develop and commercialize lerodalcibep in Greater China. Lerodalcibep is a next-generation, PCSK9 inhibitor in Phase 3 development to potentially overcome the limitations of current low-density lipoprotein lowering treatments to achieve the new national and international guidelines to treat and prevent CVD. It has the advantage of small-injection volume, monthly dosing, and long-ambient stability. LIB will receive an?upfront payment of $20million; ?future clinical, regulatory, and commercial milestone payments of up to $305 million; a percentage of net sales in Greater China.

The top 3 gainers of healthcare companies in Asia Pacific last week were Golden-Horse Pharma, Hebei Changshan Bio, and Alteogen, returning 61.2%, 51.6%, and 49%,?respectively. The bottom 3 performers were i-SENS, Jenscare, and Goush Meditech, declining 22.6%, 21.8%, and 20.3%, respectively. Please see the stock performance table at the beginning of the newsletter for more market movers. Both Golden-Horse Pharma and Changshan Bio issued statements that there was no undisclosed material information that should be disclosed. There was no information Goby News could find for the outperformance of i-SENS. Goby capital market coverage alternates between healthcare stocks in Asia and Chinese biotech stocks each week.

A Singaporean company, AWAK Technologies (private), closed one of the largest Southeast Asian medtech fundraising rounds of 2023 thus far. AWAK raised US$20 million in a Series B financing round co-led by Lion X Ventures and Vickers Venture Partners and included other investors such as Advanced MedTech, Eckuity Capital, a US-based healthcare venture capital fund, and an investment office. Funds will go towards advancing its wearable, portable dialysis device called AWAK PD to clinical trial. Read more?here.

ImmuneOnce (HKEX: 1541) continue to rise the week after its HKEX debut, rising 30.6% the last week?with average daily volume of 236,000.

The Indian pharmaceutical industry is projected to sustain at 8-10% revenue growthfor fiscal year 2024, according to new insights released by the International Register of Certificated Auditors. Price increases, new products, and increase of healthcare services across India will all likely contribute to this continued growth. Chronic therapies that address long-durational lifestyle diseases are also expected to outpace acute therapies in a trend reversal from the past two years. Read more?here.

Henlius?(HKEX: 2696)?entered an exclusive license agreement with PT Kalbe Genexine Biologics (Indonesia) for HANSIZHUANG (anti-PD-1 monoclonal antibody)?in 12 Middle East and North African countries. Henlius will receive US$7 million upfront and up to US$650 million in potential milestones plus royalties. Read more?here.

Takeda?(NYSE: TAK)?announced its commitment of $30 million+ across five new global CSR partnerships in an effort to make a positive health impact in 92 countries, specifically for marginalized and/or vulnerable groups who lack quality health services and access to essential medicines. Read more?here.

Menarini Asia-Pacific?(Singapore)?and?Astellas Pharma?(Japan) entered into a long-term exclusive partnership? for the development, manufacturing and commercialization of Smyraf in Taiwan for the treatment of rheumatoid arthritis. Smyraf is an oral JAK-inhibitor available in 50 mg and 100 mg tablets. Astellas will receive total payments of up to €5.5 million including upfront and milestone payments, plus royalties. Menarini will have an option to extend the rights to select South-East Asian markets. Read more?here.

Upcoming Virtual Roadshow and 1-1s

Date and Time: Thursday September 21st 8:30 AM ET/8:30 PM Beijing Time

Language: Mandarin Chinese Company: YS Biopharma (NASDAQ: YS), formerly Yisheng Biopharma. Market Cap: US$84 mil

FY2023 Revenue: ~$100 mil Presenter: David Shao, PhD

Company will update recent corporate activities

Upcoming catalysts: multiple clinical and business milestones ahead

Zoom Registration Link:?https://us02web.zoom.us/webinar/register/WN_TtDBpaloRLSz6SH1MtCQwQ#/registration

1-1's available for institutional investors.

Business Development

Cure Genetics?(private, Suzhou-based) and?Frametact?entered a $60 million licensing agreement to develop novel AAV vectors to treat familial neurological diseases using Cure Genetic's VELP platform. Cure Genetics will receive an upfront and milestone payment totaling $60 million, plus royalties. Read more?here.

2seventybio?and?JW Therapeuticstics?are expanding their strategic alliance to add up to two additional candidates from the 2seventy portolio, one in solid tumor indications using TCR-based tech, and a second in autoimmune disease with a CAR T cell approach. Read more?here.

Clinical and Regulatory

Clover Biopharma?launched AdimFlu-S, its quadrivalent seasonal influenza vaccine, in China. It is approved for use in individuals aged three years and older. Read more here.

BioRay Pharma?received marketing approval from China's NMPA for Zuberitamab Injection, indicated for the treatment of CD20-positive diffuse large B-cell lymphoma. This is the first domestically developed Class I anti-CD20 drug in China. Read more?here.

SINOVAC?has enrolled the first patient in its Phase II clinical trial of SA55, a broad-spectrum neutralizing antibody injection, to treat COVID-19 infections. Read more?here.

Astellas?announced the European Medicines Agency has validated its Type II variation for XTANDI to treat non-metastatic hormone-sensitive prostate cancer. Read more?here.

HUTCHMED?completed patient enrollment of a Phase II bridging study of tazemetostat in China for the treatment of relapsed/refractory follicular lymphoma. Read more?here.

InnoCare Pharma?received IND clearance from China's NMPA for a clinical trial of ICP-189, a novel SHP2 allosteric inhibitor, in combination with furmonertinib, a brain-penetrant EGFR inhibitor, to treat advanced NSCLC. Read more?here.

Dizal?announced the Chinese CDE accepted its NDA for golidocitinib for the treatment of relapsed/refractory PTCL. Read more?here.

Asieris?announced promising results will be released at an upcoming meeting from its Phase I/II clinical trial of APL-1202, an oral METAP2 inhibitor, in combination with tislelizumab as a neoadjuvant therapy for muscle invasive bladder cancer. Read more here.

Caliway Biopharma?announced it met the primary and secondary efficacy endpoints in its Phase 2 study evaluating CBL-514 to treat patients with Dercum's Disease lipomas, showing good safety and tolerance profiles. Read more?here.

Presentations

Gracell Biotech?will present at three upcoming investor conferences: Stifel Immunology & Inflammation Virtual Summit, Jefferies Cell & Genetic Summit, and the Cantor Global Healthcare Conference. Read more?here.

Foresee Pharma?presented data from its aderamastat program at the European Respiratory Society International Congress, in a presentation titled: "Effect of MMP-12 inhibitor, aderamastat (FP-025), on allergen-induced late response in asthmatic subjects". Read more?here.

Financial Results?

Connect Biopharma?released its first half of 2023 financial results. Read more here.

Prenetics?released its second quarter of 2023 financial results. Read more here.

Other

Biocytogen?Pharma?launched its RenMice series of independently-developed, fully human antibody mice and TCR mice with proprietary intellectual property. Read more?here.

Greater Asia News

Japan

Sosei Group?announced its partner?Neurocrine Biosciences?initiated its Phase 1 first-in-human clinical study to evaluate NBI-1117570, an investigational oral, muscarinic M1/M4 selective dual agonist developed to treat neurological and neuropsychiatric conditions. Read more?here.

Astellas?(TSE: 4503) will invest more than €330 million to build a new facility in Tralee, Co. Kerry in Ireland. Read more?here.

Medmain?was selected for the "U.S. Market Gateway Accelerator for BioSciences and MedTech", an acceleration program sponsored by WorldUpstart. The Company offers PidPort, an AI-powered cloud system to assist in digital pathology. Read more?here.

Takeda?received BLA acceptance from the U.S. FDA for ENTYVIO as a maintenance therapy for moderate-to-severe Crohn's disease. Read more?here.

Heartseed?presented case reports from its Phase 1/2 clinical trial of HS-001 in combination with coronary artery bypass grafting surgery for advanced heart failure at the 71st Annual Meeting of the Japanese College of Cardiology. Read more here.

HOYA Group/PENTAX Medical?announced a collaborative agreement with?IRCAD, a French research and training center, to educate physicians on advanced flexible endoscopy. Read more?here.

Takeda?announced positive topline results from its Phase 2b study evaluating TAK-279, an oral TYK2 inhibitor for the treatment of active psoriatic arthritis. The study met its primary endpoint with a greater proportion of patients treated once-daily with TAK-279 achieving at least a 20% improvement at week 12 compared to placebo. Read more?here.

Daiichi Sankyo?and?AstraZeneca?announced results from a primary analysis of its DESTINY-LUNG02 phase 2 trial of ENHERTU, an HER2 directed ADC, showing tumor responses in previously treated patients with NSCLC. Read more?here.

Daiichi Sankyo?announced updated data results from a Phase 1/2 trial of infinatamab deruxtecan, a B7-H3 directed ADC, showing tumor reduction across a range of B7-H3 protein expression levels. Read more?here.

Fujitsu?launched a Surgical Capacity Optimization technology to support perioperative executives by suggesting algorithmically-calculated recommendations to adjust block time allocation in operating rooms and streamline scheduling. Read more?here.

South Korea

Samsung Bioepis?and?Sandoz?are partnering to commercialize SB17, a ustekinumab biosimilar candidate, in Europe and North America. Read more here.

Aston Sci.?received IND clearance from the U.S. FDA for a Phase 2 trial of AST-201, an ovarian cancer vaccine that enhances T-cell immune response against specific antigens to trigger cancer cell apoptosis. Read more?here.

Oscotec/ADEL?received FDA clearance for the IND application of ADEL-Y01 for the treatment of Alzheimer's disease. ADEL-Y01 is a recombinant IgG1 class type monoclonal humanized antibody that recognizes and binds to tau protein acetylated at lysine-280 (acK280) thus inhibiting aggregation and propagation of tau seeds and enhancing microglial tau clearance. Read more?here.

J INTS BIO?presented results from its Phase 1/2 study of JIN-A02, a novel oral 4th-gen EGFR TKI to treat metastatic NSCLC at the recent 2023 World Conference on Lung Cancer. Thus far in clinical trial, there has been no DLT, no treatment-related AE, and no noted disease progression. Read more?here.

Lunit?published the results of a collaborative study with Dr. Yan Chen from the University of Nottingham in the journal?Radiology.?The study shows that Lunit's AI-powered mammography analysis solution, INSIGHT MMG, matches the diagnostic performance of human readers. Read more?here.

Wellysis?received marketing clearance from the U.S. FDA to to market S-Patch Ex, a wearable electrocardiography patch. Read more?here.

India

Orchid Pharma?signed a sublicense agreement with the Global Antibiotic R&D Partnership to manufacture cefiderocol, an antibiotic to treat certain gram-negative infections. This project to increase antibiotic access for patients in regions of the world in need also involves Japanese company?Shionogi & Co.?and the Clinton Health Access Initiative. Read more?here.?

Sun Pharma?and Illinois-based?Pharmazz?signed a licensing deal to bring Tyvalzi to India, a treatment for acute cerebral ischemic stroke. Sun Pharma will get marketing rights in India and Pharmazz will receive an undisclosed upfront payment, along with potential milestones and royalties. Read more?here.

Singapore

Genesis MedTech?received approval from China's NMPA for market release of its absorbable sutures with antibacterial protection. Read more?here.

Us2.ai?and?Duke University?are partnering to co-develop and commercialize AI tools for echocardiography for earlier detection, improved diagnosis, and more efficient management of heart disease. Read more?here.

Biosyngen Pte?received IND clearance from the U.S. FDA for a Phase I/II clinical trial of BRL03 to treat lung cancer, gastric cancer, and other solid tumors. This is also the Company's first TCR-T product to enter clinical trials. Read more?here.

Buzzreach?and?Oncoshot?entered a collaboration to accelerate clinical trials in Japan via solutions for clinical trial site recruitment and retention, project management solutions, and a real-time health insights exchange platform. Read more?here.

Conferences

Click here to view our calendar of Upcoming Conferences.

Including:

Sept 19-21, 2023:?BioFach?(Shanghai)

Sept 20, 2023:?Endpoint Biotech Awards Gala?(Boston)

Sept 20-21, 2023:?ChinaBio Partnering Forum?(Shanghai)

Sept 26, 2023:?The Third Digital Health Symposium?(NYC)

Sept 26-28, 2023:?International Medical Devices Exhibition?(Beijing)

Oct 14-17: 2023:?DenTech China 2023?(Shanghai)

Oct 19-23, 2023:?International Conference on Cholesteatoma and Ear Surgery(Shanghai)

Oct 20-24, 2023:?China Conference on Rare Diseases?(Beijing)

Oct 23-24, 2023:?G20 Global Pharma Summit Series-China?(Beijing)

Oct 28-29, 2023:?World Congress on Drug Innovation?(Shanghai)

Dec 7-8, 2023:?InnoXBio2023 Biomedical Industry Ecosystem Conference and the First Greater Bay Area Cell Gene Therapy Development Forum?(Guangzhou)