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SinoMab Announces IND APPLICATION FOR SN1011 APPROVED BY NMPA

HONG KONG, Apr 20, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 19 April 2022 (after trading hours), an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China. The planned first patient enrollment is in the fourth quarter of 2022.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study for pemphigus in the third quarter of 2022. In addition to the approval of this IND, the Company is planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022.MS is a demyelinating disease, which potentially damages the patient's brain and spinal cord. MS may cause a wide range of symptoms, including but not limited to vision problems and movement disorders. Global MS prevalence reached 2.7 million people in 2018 and is expected to increase to 3.1 million people in 2023 at a CAGR of 2.8% from 2018, and 3.7 million people in 2030 at a CAGR of 2.7% from 2023. Global MS market expanded to US$23.0 billion in 2018, and is expected to reach US$30.8 billion in 2023 at a CAGR of 6.0% from 2018, and US$48.9 billion in 2030 at a CAGR of 6.8% from 2023.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application for MS for SN1011 was accepted by the NMPA at the beginning of the year, and was approved only three months later, which fully reflects the NMPA's recognition of the Company's candidate products, and also confirms the efficient execution of the Company's new drug R&D program. The approval of this IND application is the third indication of SN1011 in China following the approval of IND application for SLE and pemphigus, fully demonstrating the great potential of our innovative BTK inhibitor in the field of the treatment of autoimmune diseases. We are absolutely confident in the enormous prospects of SN1011's clinical development, we will also accelerate clinical trials and continuously expand the scope of potential indications. In the future, we will accelerate our R&D projects implementation, devote to the vision of independent innovation, further expand the product portfolio and potential indications, dedicate to exploring safe and effective treatments for patients suffering from autoimmune diseases worldwide."About SinoMab BioScience LimitedSinoMab 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 rheumatoid arthritis 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. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

HONG KONG, Feb 7, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 21 January 2022, an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China (the "NMPA"). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of multiple sclerosis.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "after the Company announced earlier the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03, an IND application (for multiple sclerosis) for SN1011 has been filed with and accepted by the Center for the CDE of the NMPA, which will accelerate the progression of the Phase II clinical study and clinical development program related to indication for treatment of multiple sclerosis, fully reflecting the Company's efficient implementation of new drug R&D programs. We are absolutely confident in the enormous prospects of SN1011's clinical development. In the future, the Company will accelerate the program to further expand its product pipeline and strive to bring benefits to patients."About SinoMab BioScience LimitedSinoMab 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 rheumatoid arthritis 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. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Male teacher allegedly molested boy multiple times in Singapore primary school

SINGAPORE - A primary school teacher appeared in a district court on Friday (July 9), accused of molesting a boy at his workplace multiple times in 2017 and 2018. The 42-year-old Singaporean was handed five molestation charges in total. Details about the teacher, the boy and the school cannot be revealed because of a gag order. In a statement to The Straits Times, the Ministry of Education (MOE) said the man has been suspended from duty since November 2018 when the police investigation started. He is said to have first targeted the boy, who was then around 10 to 11 years old, in the school some time in late 2017. According to court documents, the man allegedly touched the child's private parts over his shorts. He is accused of committing a similar act on the boy four more times between March and October 2018. The ministry added in its statement: "MOE takes a serious view of staff misconduct and will not hesitate to take disciplinary action against those who fail to adhere to our standards of conduct and discipline, including dismissal from service." The man was offered bail of $15,000 on Friday and his case has been adjourned to Aug 5. For each count of molesting a child below 14 years old, an offender can be jailed for up to five years, fined or caned, or given any combination of such punishments. More on this topic   Related Story S'pore teacher, 38, jailed 8 months for performing indecent acts on 14-year-old girl   Related Story Jail, caning for man who molested boy in primary school

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Man accused of murdering woman in Jurong East stabbing incident had allegedly hurt her before

SINGAPORE - A 35-year-old man accused of fatally stabbing a woman in Jurong East had purportedly hurt her with a penknife in November last year. Zheng Xianfeng, a Chinese national, was facing two charges, including for last year's alleged offence, before he was charged on Thursday (Feb 18) with murdering Tham Mee Yoke. Tham, 34, was found lying motionless with multiple stab wounds at the void deck of Block 308 Jurong East Street 32 by the police, after they were alerted on Tuesday at 11.55pm. She was unconscious when taken to Ng Teng Fong General Hospital and pronounced dead at about 1.30am the next day. On Wednesday, the Singapore Civil Defence Force received a call for help at 12.05am and said that two people were taken to the hospital. The police said on Wednesday that Zheng and Tham know each other. According to court documents, Zheng is said to have voluntarily caused hurt to Tham using a penknife on Nov 17 last year at the open space carpark next to Block 349 Jurong East Avenue 1. He is also accused of causing annoyance on Jan 16 this year by lying down on the carpark near Block 316 Jurong East Street 32, and shouting while drunk. Zheng's case is expected to be heard again on March 11. Police officers at the void deck of Block 308 Jurong East Street 32 near where a woman was found lying motionless with multiple stab wounds. PHOTO: LIANHE ZAOBAO More on this topic   Related Story Man arrested for alleged murder of woman found with multiple stab wounds in Jurong   Related Story Courts & Crime: Read more stories

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Man, 20, sentenced to 1 year RTC for molesting his underage cousin over 4 years

SINGAPORE - A 20-year-old man was sentenced on Thursday (Oct 15) to 12 months at a Reformative Training Centre (RTC) for sexually assaulting his female cousin on multiple occasions between 2016 and 2019. He first molested his cousin in an apartment unit when she was 10 and he was 15. He continued to molest her on multiple occasions throughout the years, the last time being in May last year, when the man was 19 and the victim was 13. The man cannot be named due to a gag order to protect the victim's identity. The court heard that on multiple occasions, he would lock himself in a bedroom with the victim and instruct her to lie down on a mattress. He would then remove her shorts and underwear and proceed to rub his exposed genitals against her lower body and buttocks. The first time he assaulted his cousin, he was paired with her during a game of "hide-and-seek", during which he isolated her from the others they were playing with. He then locked her in a bedroom and proceeded to molest her. Most pertinently, in May last year, the accused dragged the victim - then 13 - out of the shower she was in. Despite the victim's efforts to rebuff his advances, he made her lie down on a bed and he proceeded to rub his exposed genitals against hers for around two minutes. Deputy Public Prosecutor Kor Zhen Hong noted that the accused and the victim's families shared a "close relationship", and that the victim did not confide in anyone as she was "afraid of spoiling the relationship between their families". DPP Kor added that the victim did not put up a struggle, as she respected him and "did not wish to upset him". This pattern of sexual abuse finally came to light in late May last year, when the victim's elder brother noticed that the accused and the victim were frequently spending time together in a locked bedroom. More on this topic   Related Story Paedophile, 22, gets jail, caning for molesting sister when she was 5 and raping her at age 12   Related Story Man gets 14 months' jail and 2 strokes of the cane for molesting teenage stepdaughter   Related Story Bus driver admits to molesting stepdaughter multiple times over more than 20 years He conveyed his concerns to their mother, who questioned the victim. The girl then revealed that she had been a victim of her cousin's sexual advances since 2016. A police report was finally lodged on May 30, 2019 at the Hougang Neighbourhood Police Centre, where the victim told officers that she had been "sexually assaulted". DPP Kor asked that the man be sentenced to time in an RTC, rather than given probation, as the offences had been committed over an extended period of four years. "The age gap between the accused and the victim was quite significant, and we recommend that a structured environment such as the RTC would reduce his risk of re-offending," DPP Kor said. The man was sentenced based on three proceeded charges of outrage of modesty. The first one took place between May and June 2016, the second between November and December 2018, and the third one occurred in May 2019. Four other charges of outrage of modesty were taken into consideration in the man's sentencing. More on this topic   Related Story Courts & Crime: Read more stories District Judge May Mesenas told the man prior to his sentencing that she hoped the victim would be able to "overcome and deal with what you have done to her". "I hope that after your time in RTC you will make sure that this does not happen to anyone else," Judge Mesenas said. Judge Mesenas also called on the Ministry of Social and Family Development to locate and contact the victim to follow-up with the necessary counselling. The court heard that the victim now lives with her mother - who has since remarried - and that there has been no contact between her and her cousin since the police report was made. "I would like to ask for the MSF to reach out to the victim so that the after-effects and consequences of what has occurred do not stay with her and manifest in other consequences for her down the road," Judge Mesenas said.

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