Sun Yat-Sen University

SAN FRANCISCO and SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that primary endpoint of 12-week induction period was met in a multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study (ClinicalTrials.gov, NCT05377580) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in Chinese subjects with moderately to severely active ulcerative colitis (UC). This study aims to evaluate the efficacy and safety of picankibart for the treatment of moderately to severely active ulcerative colitis (modified Mayo score of 4 to 9 with an endoscopic subscore of ≥2) consisting of induction and maintenance periods. A total of 150 subjects were enrolled and randomized in a 1: 1: 1 ratio to receive intravenous infusion of placebo, picankibart 200 mg, or picankibart 600 mg at weeks 0, 4, and 8 during the induction period. During maintenance period, subjects received subcutaneous injection of picankibart 200 mg every 4 or 8 weeks. The primary endpoint was the proportion of subjects who achieved clinical remission (per modified Mayo score, defined as a rectal bleeding subscore of 0, a stool frequency subscore of ≤1, and an endoscopic subscore of ≤1) at week 12. Secondary endpoints included the proportion of subjects who achieved clinical response, symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission compared to the placebo group. The primary and secondary endpoints were met: The proportion of subjects who achieved clinical remission was significantly higher in the picankibart 200 mg group (20.0%) and 600 mg group (14.0%) than in the placebo group (2.0%; p < 0.05). Clinical response was achieved in 54.0% and 68.0% of subjects in the picankibart 200 mg and 600 mg groups, respectively, which was significantly higher than in the placebo group (22.0%; p < 0.001). In addition, the proportion of subjects who achieved symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission in the picankibart 200 mg and 600 mg groups than in the placebo group. The overall safety profile of the picankibart groups was favorable and similar to that of previous studies and other IL-23 class drugs, with no new safety signals observed. To date, the maintenance period of the study is ongoing, and the proportions of subjects who have achieved clinical remission, clinical response, symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission have continued to increase compared to induction period. Detailed data will be further analyzed and published at future academic congresses or in clinical journals. Professor Minhu Chen, the Principal Investigator of the Clinical Study, the First Affiliated Hospital of Sun Yat-sen University, stated, "Ulcerative colitis is a chronic, recurrent inflammatory disease involving colorectal mucosa, which is related to the interaction of genetic, environmental and immune factors. its common symptoms including abdominal pain, diarrhea, rectal bleeding, weight loss and fatigue. Current treatment approaches mainly focus on controlling inflammation, alleviating symptoms, and maintaining remission. New treatment methods are urgently needed to offer more meaningful improvements. I am pleased to see that the primary endpoint was achieved in a Phase 2 clinical study of picankibart in moderately to severely active ulcerative colitis, with significant clinical benefits in the induction period and a favorable safety profile observed. I look forward to the further development of picankibart to provide more treatment options for Chinese patients with ulcerative colitis." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated: "Ulcerative colitis, as a chronic inflammatory disease, not only damages patients' physical health, but also seriously impact their daily lives and mental health. In recent years, a new generation of IL-23-targeted agents has been proven to have superior efficacy and safety for treating ulcerative colitis. Currently, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, and this Phase 2 study is the first clinical trial in China to evaluate a domestic IL-23p19 drug candidate for the treatment of ulcerative colitis. Picankibart is independently developed by Innovent, and has its first new drug application under NMPA review for treating plaque psoriasis. The encouraging results of this Phase 2 study in patients with ulcerative colitis gave us more confidence of the clinical potential of picankibart in treating more autoimmune diseases. We truly hope to bring accessible and high-quality innovative biologics to benefit a wide range of patients." About Ulcerative Colitis Ulcerative colitis is a chronic inflammatory disease characterized by mucosal inflammation of the colon and rectum, with typical symptoms such as recurrent diarrhea, mucus, pus and blood stool with abdominal pain, and urgency. Ulcerative colitis is a serious threat to physical health and has an impact on daily life and mental health for patients. Ulcerative colitis is common in Europe and North America. And in China, the prevalence rate has been increasing gradually in the past 20 years with a prevalence rate of 11.6/100000. Ulcerative colitis is more common diagnosed in young and middle-aged people. The clinical treatment of ulcerative colitis is mainly medication and surgical treatment. Thiopurine is the most traditional immunosuppressant, however the incidence of adverse reactions is high. In terms of biologics, anti-TNF-α Monoclonal antibodies have problems such as loss of response caused by immunogenicity. In recent years, drugs targeting IL-12 and IL-23 have shown advantages in efficacy and safety in the treatment of ulcerative colitis. At present, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, representing a huge unmet clinical need. About Picankibart (IBI112) Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases. Currently, multiple clinical studies of picankibart are underway, including: Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024; Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment; Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics; Phase 2 study in patients with moderate to severe active ulcerative colitis. In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 14, 2024 /PRNewswire/ -- Baird Medical Investment Holdings Ltd. (NASDAQ: BDMD) ("Baird Medical" or the "Company"), a leading developer and provider of microwave ablation ("MWA") medical devices in China, which recently expanded into the U.S. market following its U.S. FDA 510(k) clearances, today announced its participation in the upcoming American Thyroid Association (ATA) Annual Meeting. The event is scheduled to take place from October 30 to November 3, 2024, at the Sheraton Grand Chicago Riverwalk in Chicago, Illinois. Baird Medical will showcase its innovations at Booth 100, one of the largest exhibitor spaces at the event, featuring the Company's latest advancements in MWA technology and highlighting its impact on thyroid care. During the event, the Company will also host an Expo Theater Presentation on November 2, 2024, from 10:25 AM to 11:25 AM, inside the Exhibit Hall of the Chicago Ballroom. The session, titled "Latest Advancements in MWA for Thyroid Treatment," will provide valuable insights into recent developments in this field. It will feature Dr. Emad Kandil from Tulane University, Dr. Feng Than from Sun Yat-sen University, and Dr. Khadra Helmi from Houston Methodist Hospital. "We are excited to participate in the ATA Annual Meeting and present our innovations in microwave ablation technology," said Haimei Wu, Co-Founder of Baird Medical. "This event is an excellent opportunity to engage with leading experts and foster meaningful relationships to advance thyroid care. We warmly invite all attendees to visit our booth and attend our Expo Theater Presentation to explore our cutting-edge MWA technology." Baird Medical's participation in the event underscores its expansion into the U.S. market, following a successful listing on the Nasdaq exchange. The Company's recent FDA clearance for its minimally invasive microwave ablation technology offers a promising alternative to thyroidectomy for patients with benign thyroid tumors. With over 150,000 thyroidectomies performed annually in the U.S., Baird Medical's minimally invasive microwave ablation offers a safer, less invasive alternative for treating benign thyroid tumors. About the ATA® Annual Meeting The ATA® Annual Meeting is the world's preeminent event for those interested in thyroid diseases and disorders. It's an opportunity for peer-to-peer learning and collaboration through lectures, interactive discussions, meet the professor sessions, and abstracts. About Baird Medical Established in 2012 and headquartered in Guangzhou, China, Baird Medical is a leading microwave ablation ("MWA") medical device manufacturer and provider in China and a recent entrant to the United States market. Baird Medical's proprietary devices are used to treat both benign and malignant tumors, including thyroid nodules, liver cancer, lung cancer, and breast lumps. Baird Medical is the first company to obtain a Class III medical devices registration certificate for MWA medical devices specifically indicated for thyroid nodules in China. For more information, please visit . Contacts Investor Relations Robin Yang, Partner ICR, LLC Phone: +1 (646) 308-1475 Email: [email protected] Public Relations Brad Burgess, Senior Vice President ICR, LLC Phone: +1 (646) 588-0383 Email: [email protected] SOURCE Baird Medical Investment Holdings Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China I September 28, 2024 I From September 25 th to 29 th , the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference. TNBC On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session. The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator’s choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients. Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women’s lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.” NSCLC On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion. Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B. Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.” CC On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%. Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.” EC/OC On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%. 40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE). Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.” With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030. SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co.