AUSTIN, TX, Jul 13, 2022 – (ACN Newswire) – Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today the marketing authorization of the Apollo ESG(TM), Apollo ESG Sx(TM), Apollo REVISE(TM) and Apollo REVISE Sx(TM) Systems through the U.S. Food and Drug Administration's (FDA) De Novo Classification process, a rigorous pre-market review pathway for low-to moderate-risk devices without a predicate. These are the first and only devices authorized by the FDA for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision.

ESG is an incisionless procedure that utilizes an endoscopic suturing system to reduce the volume of a person's stomach and delay emptying of the stomach, resulting in clinically meaningful, durable weight loss. In a randomized controlled trial, the ESG procedure demonstrated safety and effectiveness with durability out to two years.[1] The results from this trial add to a larger body of evidence reporting outcomes in over 10,000 patients receiving ESG. ESG can be performed as a same-day procedure without incisions or scars, and patients typically return to work within a few days.

Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.[2] Studies have shown that after ten years, patients who underwent gastric bypass have regained an average of 20-30% of the weight they initially lost.[3] Transoral outlet reduction (TORe) is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

"The Apollo ESG and Apollo REVISE systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity," said Chas McKhann, President and CEO of Apollo. "The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic."

Obesity, defined as BMI >30 kg/m2, is a complex, chronic disease that affects 650 million adults globally.[4] In the US, 108 million adults and 42% of the population suffer from obesity[5], which is expected to increase in prevalence by 33% in the coming decades.[6] Obesity contributes to an estimated $147-210 billion in annual healthcare expenditures and is associated with many comorbid conditions.[7] Obesity is considered a major risk factor for type 2 diabetes; the CDC cites that 62% of people with diabetes are obese.[5] Obesity is also a risk factor for heart disease, high blood pressure, liver disease, osteoarthritis, and many types of cancer.[7] The primary treatment for obesity is weight loss, though currently, less than 0.2% of adults with obesity are treated surgically for obesity, leaving a substantial unmet need.[2],[8]

Apollo ESG and Apollo REVISE join Apollo's growing portfolio of endoscopic solutions for weight loss in patients with obesity. The Apollo ESG and Apollo ESG Sx Systems are intended to be used by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity with Body Mass Index (BMI) between 30-50 kg/m2 who have not been able to lose weight or maintain weight loss through more conservative measures. The Apollo REVISE and Apollo REVISE Sx Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI between 30-50 kg/m2 by enabling transoral outlet reduction (TORe) as a revision to a previous bariatric procedure. The systems are used with a dual channel endoscope (Apollo ESG and Apollo REVISE) or single channel endoscope (Apollo ESG Sx and Apollo REVISE Sx).

For more information regarding the De Novo marketing authorization of these systems, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm, which may be updated to reflect this decision at a future date.

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, minimally invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions, including closure of gastrointestinal defects, managing gastrointestinal complications, and weight loss as a treatment of obesity. Apollo's device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 75 countries today and include the OverStitch(R) Endoscopic Suturing System, the OverStitch Sx(TM) Endoscopic Suturing System, the Orbera(R) Intragastric Balloon System, the X-Tack(R) Endoscopic HeliX Tacking System, as well as the Apollo ESG(TM), Apollo ESG Sx(TM), Apollo REVISE(TM) and Apollo REVISE Sx(TM) Systems.

Apollo's common stock is traded on NASDAQ Global Market under the symbol "APEN". For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.

About Apollo ESG(TM) and Apollo REVISE(TM)

The Apollo ESG(TM) and Apollo REVISE(TM) Systems are intended to facilitate weight loss in patients with obesity (BMI 30-50 kg/m2) and are the first and only devices to be authorized by the FDA for performance of ESG and TORe, respectively. ESG and TORe are performed endoscopically without incisions or scars, allowing patients typically to go home the same day. More than 25,000 ESGs and more than 10,000 endoscopic revision procedures have been performed worldwide by gastroenterologists and surgeons. To review the full indications for use, visit www.apolloendo.com/dfus.

Legal Notice Regarding Forward-Looking Statements

Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it may have on the Company's operations, the Company's financial outlook for future periods, the demand for the Company's products, the Company's liquidity position, global supply chains and economic activity in general. Important factors that could cause actual results to differ materially include: adverse events related to the Company's products, outcomes of clinical studies related to the Company's products, development of competitive medical products by competitors, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities, unfavorable media coverage related to the Company's products or related procedures, coverage and reimbursement decisions by private or government payors, the Company's ability to support the adoption of its products and broaden its product portfolio as well as other factors detailed in Apollo's periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the period ended March 31, 2022. Copies of reports filed with the SEC are posted on Apollo's website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

[1] Abu Dayyeh B, et al. Endoscopic sleeve gastroplasty impact on obesity and comorbidities: results from a US prospective, multicenter, randomized clinical trial with 104 weeks follow-up. Digestive Disease Week; May 24, 2022. Oral presentation.
[2] ASMBS. Estimates of bariatric surgery numbers, 2011-2020.
[3] Adams TD, et al. Weight and metabolic outcomes 12 years after gastric bypass. N Engl J Med 2017;377:1143-55.
[4] World Health Organization, June 2021
[5] Centers for Disease Control and Prevention
[6] Finkelstein E, et al. Obesity and Severe Obesity Forecasts Through 2030
[7] Obesity Action Coalition
[8] O'Brien P. Surgical Treatment of Obesity. Endotext (Internet)

CONTACT:
Apollo Endosurgery, Inc.
Jeff Black, Chief Financial Officer, 512-279-5126
investor-relations@apolloendo.com

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com

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HONG KONG, Jul 8, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-listed biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative therapeutics for the treatment of immunological diseases, primarily mAb-based biologics, is pleased to announce that, the Company has received HK$8 million subsidy from the Hong Kong Science and Technology Parks Corporation ("HKSTP"), which is the highest subsidy amount in the Clinical Translational Catalyst (CTC) program of HKSTP.

CTC program is offered by HKSTP Institute for Translational Research (ITR), the overarching aim is to provide a platform to transform Hong Kong and Greater Bay Area to become the go-to destination for translational medicine in the region. Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.

SinoMab stood out from many biopharmaceutical companies in the CTC program and was granted the highest subsidy amount, embodying the recognition by the evaluation committee on the Company's product candidates and research and development (R&D) plan. According to the agreement signed by both parties, HKSTP will provide SinoMab a subsidy of HK$8 million in the next 42 months in phases according to its clinical plan and progress for the clinical study of SN1011, the Company's key product, for the treatment of multiple sclerosis (MS).

SN1011 is SinoMab's key product and third-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor. Following the approval of Investigational New Drug (IND) applications of SN1011 for systemic lupus erythematosus (SLE) and pemphigus vulgaris (PV) by the National Medical Products Administration (NMPA) on 27 August 2020 and 23 June 2021, respectively, the IND application of SN1011 for MS has been approved by the NMPA on 19 April 2022. The Company plans to initiate Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with MS in China and expects to enroll the first patient in the fourth quarter of 2022. The IND application of SN1011 for neuromyelitis optica spectrum disorder (NMOSD) was also accepted by the Center for Drug Evaluation (CDE) of the NMPA on 6 June 2022.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "By launching the CTC program, HKSTP provides great support to local biopharmaceutical companies on their New Drug R&D. As a biopharmaceutical company raised in Hong Kong for 20 years, we are grateful for the long-term support and assistance of the HKSTP in promoting innovation and development of local biopharmaceutical companies. Previously, President Xi Jinping, and the Chief Executive of the HKSAR, Mr. Lee Ka-chiu, visited the Science Park, with the desire to forge Hong Kong into an international Innovation and Technology hub, demonstrating the country's high appreciation of Hong Kong innovative technology development. We are excited by the unprecedented opportunities. With the smooth progress of clinical trials of the Company's key candidates, the subsidy from the HKSTP will provide a solid foundation for the Company's continuous R&D and stepping toward commercialization. We will fully grasp the opportunity to accelerate the R&D and clinical trials of various products, further expand the product pipeline and potential indications, speed up the realization of product commercialization, adhere to the concept of independent innovation, strive for the well-being of patients and create value for shareholders."

About Hong Kong Science and Technology Parks Corporation
Established in 2001, HKSTP attracts and nurtures talent, accelerates and commercializes innovation and technology for entrepreneurs on their journey of growth in Hong Kong, to the Greater Bay Area, Asia and beyond. Its growing innovation ecosystem is built around its key locations of the Hong Kong Science Park in Shatin, InnoCentre in Kowloon Tong and three modern INNOPARKs in Tai Po, Tseung Kwan O and Yuen Long. The three INNOPARKs are realizing a vision of re-industrialisation for Hong Kong. The goal is sectors like advanced manufacturing, electronics and biotechnology are being reimagined for a new generation of the industry.

Through its infrastructure, services, expertise and network of partnerships, HKSTP will help establish innovation and technology as a pillar of growth for Hong Kong, while reinforcing Hong Kong's international I&T hub status as a launchpad for global growth at the heart of the GBA innovation powerhouse.

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for RA in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


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