Goby Asia Healthcare Weekly 7/2

Highlights of the Week

Citing “people familiar with the matter,"?Reuters reported that Shein,?the Chinese online fashion retailer worth more than $60 billion,?has confidentially filed for an IPO in the U.S. The offering could be the biggest after Didi’s listing in 2021.?However, some U.S. congressmen have requested the SEC to verify the company does not use forced labor before the IPO is allowed. The company issued a statement denying the report. Read more?here.

The new rules for offshore listings China introduced on March 31 has slowed down the pace of Chinese companies listing in Hong Kong and western countries.?According to this Reuters’ article, 52 companies have applied since the new rule.?CSRS has accepted only 14 as of June 15; only 2 of those companies have won the approval to be listed in Hong Kong. 38 other companies need to submit additional documents.?Out of the 52 applicants, 43 are for Hong Kong and 9 are for the U.S. Combined with the news above, it showed US is still a viable option for Chinese company IPOs despite geopolitical tensions.?Read more?here.

Shanghai MicroPort MedBot (HKEX: 2252) is the best weekly gainer this week in the Asia-Pacific region,?returning 34.1%. It received the CE Mark for its DFVision 3D electronic laparoscope, used in intraoperative exploration and imaging for laparoscopic surgery of abdominal and thoracic organs.?Everest Medicines (HKEX: 1952) is the second best performer. It was the best performer the week before last, resulting?in a more than doubling in the last 4 weeks. Read more?here.

Japan’s Sosei Group Corporation (TSE: 4565) is the worst weekly performer this week in the Asia-Pacific. Its share price almost cut in half.?Its partner Pfizer announced that it will terminate the development of obesity and diabetes pill, lotiglipron, an oral GLP-1 receptor agonist, due to elevated liver enzymes in clinical trials. Investment bank?Jefferies also downgraded Sosei Group to underperform from buy?and cut its price target from 4,200 Yen to 1,800 Yen.?Please see the table at the beginning for other market movers for the week. Goby Global monitors more than 900 public healthcare companies in the Asia Pacific region with market caps more than US$250 million.?Read more?here.

US FDA approved the first cell therapy called Lantidra from CellTrans?(private, based in Chicago)?for patients with Type 1 diabetes?who have had repeated severe hypoglycaemic episodes, despite intensive diabetes management. In two open-label studies, 70% patients did not need insulin injections for a year or more. Read more?here.?

Shinogi & Co.?(Osaka, Japan)?announced that its New Jersey-based subsidiary?Shinogi Inc. will acquire?Qpex Biopharma?with an upfront payment of $100 million to Qpex equity holders, who may also eligible to receive additional milestone payments for a total potential additional consideration of $40 million. Read more?here.

In connection with?Shinogi's acquisition of?Qpex, Brii Biosciences?announced?that it will acquire exclusive global rights or BRII-693 (expanded from its existing Greater China rights) and return the exclusive Greater China rights to QPX7728-based products BRII-636 and BRII-672 to Qpex. Brii Biosciences will receive an upfront cash payment of $24 million upon closing of the acquisition as a Qpex shareholder and the return of the QPX7728 product rights. Read more?here.

Greater China News

Capital Markets & Financing?

Foresee Pharmaceuticals?raised $42.3 million from completing an underwritten public offering of 17,500,000 shares of its common stock to the public at a price of $2.43 per share. Read more?here.

Business Development

Pharmadule Morimatsu?and?WuXi Biologics?entered into a global strategic cooperation for the Singapore CRDMO Center project of WuXi Biologics. Pharmadule Morimatsu will use its new modular fabrication methods for the integrated modular plant. Read more?here.

Innovent?and?RemeGen?entered into a clinical trial collaboration and supply agreement for the combination therapies of TYVYT with RC88 (a novel mesothelin(MSLN)-targeting ADC) or RC108 (a c-Met-targeting ADC) to treat advanced solid tumors. Innovent will provide TYVYT and RemeGen will conduct Phase 1/2a clinical studies. Read more?here.

Shineco?and?Kangling Medical?entered into a cooperation agreement to establish a joint venture company, Shangkang Life Science and Technology, to improve healthcare service and medical product access in China. Read more?here.

LianMedical?and?CereVasc?entered a corporate partnership to introduce CereVasc's eShunt system and related medical technology products to China. Read more?here.

Clinical and Regulatory?

LianBio?received marketing approval from the Singapore HSA for CAMZYOS as a treatment for symptomatic obstructive hypertrophic cardiomyopathy. Read more?here.

Sihuan Pharmaceutical Holdings?announced its subsidiary?Xuanzhu Biopharmaceutical?received drug registration approval from the Chinese NMPA to market its anaprozole sodium enteric-coated tablets for the treatment of duodenal ulcers. Read more?here.

Aurisco?received its first marketing authorization approval in China for AUXITON, the oral form of dydrogesterone, a highly selective progestogen receptor agonist. Read more?here.

Junshi Biosciences?received clearance from the U.S. FDA?to officially initiate a Phase 3 study in the near future of tifcemalimab plus toripalimab for the treatment of limited-stage small cell lung cancer. Read more?here.?

Caliway Biopharmaceuticals?released updated results from its Phase 2-Stage 1 clinical trial of CBL-514, showing 1-level improvement in cellulite severity two weeks after a single treatment. CBL-514 is the Company's lead drug candidate, a non-surgical lipolytic injection designed to reduce local fat by inducing adipocyte apoptosis and lipolysis. Read more?here.

CANbridge Pharmaceuticals?reported positive preliminary results from its ongoing Phase 1b study of omoprubart (CAN106), showing promising efficacy and safety with four-week extended dosing. Read more?here.

Drug Farm?received IND clearance from the U.S. FDA to initiate a Phase 1 trial of DF-003, a first-in-class oral ALPK1 inhibitor intended to treat heart and kidney-related diseases. Read more?here.

Harbour BioMed?announced the Chinese NMPA accepted its Biologics License Application of batoclimab for the treatment of generalized myasthenia gravis. This is the company's first BLA accepted by the Chinese NMPA since its founding. Read more?here.

People

Burning Rock?announced the resignation of Dr. Shaokun Chuai as a director from the Board and as the Chief Scientific Officer. Dr. Chuai will continue to serve as a senior advisor. Read more?here.

Presentations

Jacobio Pharma?presented clinical results of its novel KRAS G12C inhibitor glecirasib as a monotherapy and in combination with cetuximab to treat colorectal cancer at the second JCA-AACR Precision Medicine International Conference. Read more?here.

Ascletis?announced a poster presentation on ASC42, a farnesoid X receptor (FXR) agonist in combination with PEGylated interferon and entecavir in chronic hepatitis B (CHB) patients, at the European Association for the Study of the Liver Congress. Read more?here.

Henlius?held its first overseas Scientific Advisory Board meeting of 2023 in California. Read more?here.

Financial Results

HUTCHMED released its 2023 half-year financial results. Read more?here.

Greater Asia News

Japan

Astellas?announced positive topline results from the Phase 3b DAYLIGHT clinical trial of fezolinetant for the treatment of menopausal vasomotor symptoms which showed a statistically significant reduction from baseline in the frequency of moderate-to-severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Read more?here.

Astellas?established an open innovation hub called TME iLab for tumor microenvironment research in a lab operated by Mitsui Fudosan. Read more?here.

South Korea

MEDICAL IP?announced that DeepCatch, its CT-based automatic body composition analysis AI software, received US FDA 510(k) clearance. Read more?here.

Kalos Medical?received Innovative Medical Device Designation from the Korean MFDS for its DENEX hypertension treatment system which uses minimally invasive renal denervation technology to lower blood pressure. Read more?here.

SK bioscience?signed a research collaboration agreement with the?Doherty Institute for Infection and Immunity?to develop a next-generation influenza vaccine. Read more?here.

Singapore

Specialised Therapeutics?announced MINJUVI was approved for use in Australia to treat diffuse large B-cell lymphoma. Read more?here.

Biosyngen?opened a new cell therapy GMP facility in Singapore to support cell manufacturing for immunotherapies in Singapore, as well as globally in the next three to five years. Read more?here.

Conferences

Click?here?to view our calendar of Upcoming Conferences.

Including:?

July 1-4, 2023:?European Academy of Neurology Congress?(Budapest, Hungary)

July 10, 2023:?TD Cowen 2nd Annual RNA Virtual Therapeutics Summit?(Virtual)

July 11, 2023:?Mizuho Securities 4th Annual Therapeutics Expert Seminar?(Virtual)

July 16-20, 2023:?Alzheimer's Association International Conference?(Amsterdam, Netherlands)

July 17-18, 2023:?TD Cowen Rounds @ Cleveland Clinic?(Cleveland, Ohio)