E-Week Pharma News: Crackdown on Online Drug Sales, New NMPA Leadership, and Major Executive Shifts at Novartis, Pfizer, Janssen, and Sanofi

Sep 10, 2023 21:22 CST Updated 21:22

Novartis

Drug Development and Manufacturing

Sanofi

Pharmaceutical R&D Developer

Xian Janssen

Pharmaceutical R&D and Manufacturer

Biogen

New Drug Developer

Seagen

Monoclonal Antibody Developer

Nurix Therapeutics

Small Molecule Drug Developer

Junshi Biosciences

Innovative Drug Developer

RemeGen

Biological New Drug Developer

SinoMab

Biopharmaceutical Manufacturer

SparX

Developer of Immuno-Oncology Therapies

Zenas BioPharma

Biopharmaceutical Manufacturer

Bristol-Myers Squibb

Biopharmaceutical and Nutritional Product R&D and Sales

Zai Lab

Innovative Global Biopharmaceutical Company

Neurophth

Ophthalmic Gene Drug Developer

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

Luye Pharma

Innovative Drug Developer

ImageneBio

Innovative Immunotherapy Developer

HealZen Therapeutics

Innovative Small-Molecule Drug Developer

ImmuneOnco

Developer of Anti-Tumor Immunotherapy Products

Minsheng Healthcare

Developer, Manufacturer, and Distributor of Over-the-Counter Drugs and Health Supplements

Grit Biotherapeutics

Developer of Immunotherapy Drugs for Solid Tumors

NanoMicro Technology

Core Microsphere Material and Related Technology Solutions Provider

Golden September, Silver October. In the first week of September, significant personnel changes occurred across the board, involving regulatory authorities, multinational pharmaceutical giants, and domestic Biotech companies in China.

In the past week, the National Medical Products Administration (NMPA) underwent a leadership change, with Li Li succeeding Jiao Hong as the director; Martin Taylor will become the WHO representative in China. Major pharmaceutical companies continue to see personnel changes: Novartis’ “global second-in-command” Chumo Li resigned, and China President Danieletto Bednarek is set to step down; Sanofi implemented major structural changes in China, with former China head Wang Shi appointed as the president of Sanofi Greater China; Biogen appointed a new head of R&D; Xian Janssen appointed Chen Huang as its new president for China. Meanwhile, Junshi Biosciences' executive director and core technical expert Feng Hui resigned, and RemeGen’s chief financial officer also stepped down...

At the policy level, the National Healthcare Security Administration issued the "Notice on Doing a Good Job in the Management of Medical Consumables Payment under Basic Medical Insurance," which industry insiders believe marks the era of "one unified plan for China" for medical consumables, following in the footsteps of pharmaceuticals entering the medical insurance catalog.

China's National Medical Products Administration (NMPA) released the "Guiding Principles for Inspection of Third-Party Platforms for Online Drug Transactions," proposing 17 inspection items and 40 key inspection points, indicating that online drug sales will face stricter regulation.

What are the other major events happening this week?

Policy Updates

NMPA "Changes Leadership," Li Li Takes Over from Jiao Hong as Director

On September 6, the Ministry of Human Resources and Social Security announced the appointment and dismissal of state personnel by the State Council.

Li Li Appointed as Director of the National Medical Products Administration, Jiao Hong (Female) Relieved of Duty

The official website of the National Medical Products Administration shows that Li Li was once a member of the Party Leadership Group of the State Administration for Market Regulation, and the Secretary of the Party Leadership Group and Deputy Director of the National Medical Products Administration.

Public information shows that Li Li was born in Jiangxi Province in 1962. After starting work in 1981, Li Li worked at Dayu County People's Hospital in Jiangxi until 1993, then transferred to become the Director of the Dayu County Health Bureau; from 1994 to 1999, Li served as the Deputy Director of the Ganzhou Regional Health Bureau in Jiangxi, among other positions; starting July 1999, Li served as the Deputy Director of the Jiangxi Provincial Health Department; in March 2007, Li became the Director of the Jiangxi Provincial Health Department, among other roles; from 2013 to 2016, Li served as the Director and Party Secretary of the Jiangxi Provincial Health and Family Planning Commission; and from 2016 to 2018, Li held the position of Vice Governor and Party Member of the Jiangxi Provincial People’s Government.

Transferred to the National Medical Products Administration in 2018. From 2018 to 2023, served as a member of the Party Leadership Group of the State Administration for Market Regulation, and as the Secretary of the Party Leadership Group and Deputy Director of the National Medical Products Administration.

CDE Releases 2022 Annual Report on the Progress of Clinical Trials for New Drug Registrations in China

On September 7, the Center for Drug Evaluation of the National Medical Products Administration released the重磅 report "Annual Report on the Progress of New Drug Registration Clinical Trials in China (2022)." The report shows that in 2022, the total number of clinical trials registered on the Drug Clinical Trial Registration and Information Disclosure Platform reached a record high (over 3,410), but the number of new drug clinical trials slightly decreased compared to 2021.

Analysis of Sponsor Types by Application Number Type: In the clinical trials registered in 2022, domestic sponsors still accounted for the majority at 88.5%. Compared with 2021, the proportion of overseas sponsors decreased by 10% (to 11.5%), the lowest in the past four years.

In 2022, the indications for chemical drugs were still dominated by anti-tumor drugs, accounting for 36.7% of the total number of clinical trials of chemical drugs, followed by anti-infective drugs, dermatological and ENT drugs, drugs for circulatory system diseases, and drugs for respiratory system diseases and anti-allergy drugs. In terms of the number of clinical trials, there has been an increasing trend year by year. In 2021, the total number of clinical trials was nearly twice that of 2019, with 43 trials in 2021 compared to 23 in 2019, and a total of 68 trials were registered in 2022.

Notably, the 2021 version mentioned that drug action targets were relatively concentrated in 2019, 2020, and 2021, with PD-1 and PD-L1 being particularly prominent, as their proportion in Phase III clinical trials was higher than other targets. However, the latest 2022 version contains almost no description of the target situation.

National Healthcare Security Administration Releases "Notice on Doing a Good Job in the Management of Medical Consumables Payment under Basic Medical Insurance"

On September 5, the National Healthcare Security Administration issued the "Notice on Doing a Good Job in the Management of Medical Consumables Payment for Basic Medical Insurance" (hereinafter referred to as the "Notice"), which mainly includes key matters such as inclusion scope, access management, and payment policies.

The Notice proposes to strengthen the management of medical insurance access and promote the establishment and improvement of a medical consumables medical insurance access system. Standardize the procedures for determining the medical insurance catalog. Establish and improve a dynamic adjustment mechanism. Adhere to the functional orientation of "ensuring basic needs," and include clinically essential, safe, effective, and reasonably priced medical consumables into the scope of medical insurance payments according to procedure. In principle, medical consumables with low clinical value, prices or costs far exceeding the affordability of the fund and patients, as well as non-therapeutic rehabilitation devices, shall not be included in the scope of medical insurance payments. During the "14th Five-Year Plan" period, it is necessary to complete the formulation of a unified basic medical insurance medical consumables directory for the entire province (autonomous region, municipality) using the access method. Explore ways such as access negotiations to reasonably determine the payment standards for some high-value medical consumables. For medical consumables with the same function and purpose, similar materials and characteristics, clinically interchangeable, and convergent medical insurance management, a unified payment standard can be formulated. Establish a monitoring and evaluation mechanism for medical insurance payments, focusing on monitoring medical consumables with high clinical usage, large fund consumption, and heavy patient burden.

Regarding this entirely new standard, industry insiders believe it will redefine every aspect of the production, market access, and marketing of domestically produced medical consumables in China, marking the beginning of an era where, following pharmaceuticals, medical consumables officially move towards a unified "national strategy" for medical insurance catalog access.

NMPA Releases Guiding Principles for Inspection of Third-Party Platforms for Online Drug Transactions

On September 6, the National Medical Products Administration (NMPA) publicly solicited opinions on the "Guiding Principles for Inspection of Third-Party Platforms for Online Drug Transactions (Draft for Comments)" (hereinafter referred to as the "Guiding Principles"), and announced key inspection points for third-party platforms for online drug transactions. The deadline for public comments is September 15, 2023.

The "Guiding Principles" propose to carry out comprehensive supervision and inspection of third-party platforms for online drug transactions. According to the "Guiding Principles," the inspection of third-party platforms is divided into four major aspects: record-filing and qualification review, system construction, operation management, and prescription drug sales. There are 17 inspection items, covering 40 key points of inspection including record-filing, qualification review, registration files, signing agreements, organizational structure, personnel and training, policy documents, record keeping, compliance operations, displaying licenses, delivery management, inspection and monitoring, handling violations, prescription sources, information display, and risk control.

Among the key areas of operation management, special attention is given to inspecting whether the merchants on the platform are engaging in over-the-scope or inappropriate drug sales practices. It explicitly prohibits the sale of banned products by these merchants; forbids any buy-one-get-one-free promotions involving medicines; and mandates that information regarding the qualification of legally assigned pharmacists or other pharmaceutical professionals be displayed as required.

In terms of the review of prescription drug sales on the platform, merchants are urged to ensure that the source of prescriptions is genuine and reliable, and implement a real-name system; strictly conduct prescription review and dispensing according to regulations; take effective measures to avoid the repeated use of prescriptions; verify and sign agreements with electronic prescription providers; display prescription drugs and over-the-counter drugs separately with clear indications; and do not display package inserts or provide related services for purchasing prescription drugs before prescription review.

Large pharmaceutical

Novartis' "Global No. 2 Figure" Chumu Li Resigns, China President Bednarski to Step Down

On September 6, U.S. time, Novartis announced on its official website that Marie-France Tschudin, President of Innovative Medicines International and Chief Commercial Officer, has decided to leave the company and will step down from the Novartis Executive Committee, with her last working day being September 15.

Patrick Horber, M.D., Senior Vice President and President of Immunology at AbbVie, will join Novartis as President of Novartis International and become a member of the ECN, effective later this year. Patrick Horber will report directly to Vas Narasimhan, M.D., Chief Executive Officer of Novartis. Prior to Patrick Horber assuming his role, his responsibilities will be temporarily fulfilled by Mukul Mehta, Chief Financial Officer of Novartis International.

According to foreign media reports, with this personnel change, Novartis has also eliminated the title of Chief Commercial Officer. A Novartis spokesperson said in an email: "The U.S. and international regions will collaborate strongly to lead Novartis' commercial activities, especially for certain key commercial decisions where a unified perspective from Novartis is crucial, thus the CCO role itself is no longer necessary."

In the same week, Karen Hale, General Counsel of Novartis, and Marie-France Tschudin, Global Chief Commercial Officer and President of International Innovative Medicines at Novartis, announced to employees in China that Dan Brindle, President of Novartis Group China, had decided to leave Novartis "to pursue an exciting external opportunity."

Bednarski Will Officially Step Down at the End of This Month (September 30). The Successor Has Been Determined. Starting from October 1, Zhang Ying (Ingrid), the Current President of Novartis Innovative Drugs China, Will Assume the Role of President of Novartis Group China in Addition to Her Current Position.

Major Restructuring at Sanofi China

Recently, Sanofi announced a major restructuring of its China operations, establishing three new global management positions and forming two new leadership teams in China.

Three New Positions Established: The position of President of Greater China for Sanofi has been created and will be assumed by Shi Wang, the former President of China. Shi Wang will collaborate with key functional departments to comprehensively lead Sanofi’s overall business in China, including the Specialty Care, Vaccines, and General Medicines divisions. The consumer healthcare business structure remains unchanged. The position of Head of R&D in China has been established, with the appointee to be announced later. The position of Head of Manufacturing and Supply Chain in China has also been created and will be taken up by He Guoling, the former head of Industrial Affairs in China. Two new management teams have been formed: the China Strategy Leadership Team and its extended team.

Xian Janssen Appoints New President in China: Zheng Lei Departs, Huang Chen Returns

According to industry media reports, on September 5, Xian Janssen announced the new president of its China region.

Huang Chen, Regional Managing Director of Janssen Pharmaceutical's North Asia region and CEO of Korea, will succeed Zheng Lei as the new president of Xian Janssen and lead the business development of Janssen Pharmaceutical in China. Xian Janssen also announced that Zheng Lei, the former president of Xian Janssen China, has left Johnson & Johnson.

Public information shows that Huang Chen joined Johnson & Johnson in 1997 as a financial analyst. From 2011 to 2015, he served as the financial head of Xian Janssen. Later, he successively held the positions of Senior Financial Director for Southeast Asia at Johnson & Johnson and Chief Financial Officer for the Asia-Pacific region at Janssen Pharmaceuticals. In May 2021, Huang Chen became the CEO of Janssen Pharmaceuticals' South Korea branch and was also responsible for business in Hong Kong and Taiwan, China.

Biogen Appoints New R&D Head

On September 6, Biogen announced that it would appoint Dr. Jane Grogan as Executive Vice President and Head of the R&D department, effective October 2, 2023. At the same time, Jane Grogan will also become a member of Biogen's Executive Committee, reporting directly to President and Chief Executive Officer Christopher A. Viehbacher.

Seagen Collaborates with Nurix to Develop Degrader-Linked Antibody Drugs

On September 7, Nurix announced a collaboration agreement with Seagen to jointly develop multiple antibody conjugated degrader drugs (DAC). Seagen paid $60 million upfront, $3.4 billion in milestone payments, and a certain percentage of sales royalties.

Two Companies Decide to Co-Develop a New Drug Form DAC, Integrating ADC and Protein Degrader Technologies.

Biotechnology

Junshi Biosciences' Executive Director and Core Technical Staff, Feng Hui, Resigns

On September 2, Junshi Biosciences announced that Feng Hui, executive director and core technical personnel, had applied to resign from his positions as Chief Operating Officer and other roles in subsidiaries for personal reasons, effective August 31, 2023. After his resignation, Feng Hui will be transferred to serve as a non-executive director of the company. The company will hire him as a technical consultant to ensure the smooth progress and successful transition of relevant R&D work.

According to the announcement, Mr. Feng Hui has served as the Executive Director of the company since March 2015; Chief Operating Officer of TopAlliance Biosciences Inc. (Top Alliance) since January 2014; Executive Director and Legal Representative of Shanghai Junshi Bioengineering Co., Ltd. since June 2016; and Executive Director and General Manager of Suzhou Junmeng Biomedical Technology Co., Ltd. since August 2017.

During his tenure at Junshi Biosciences, Feng Hui mainly participated in the early-stage research and development work of multiple antibody drug projects, including JS001, JS002, and JS004. The key R&D personnel involved in leading and participating in the aforementioned ongoing projects and core technologies also include two core technical experts, Mr. Zhang Zhuobing and Mr. SHENG YAO (Yao Sheng). The departure of Mr. Feng Hui will not affect the progress or implementation of these ongoing projects and core technologies.

Jafron Appoints New Vice General Manager

Jafron Biotech Group announced that the eighth meeting of the Board of Directors has reviewed and approved the "Proposal on the Appointment of Vice General Manager". According to the "Company Law", "Articles of Association" and other relevant regulations, and in combination with the development needs of the company, upon the nomination of the General Manager, the Board agreed to appoint Wang Rui as the Vice General Manager. The term of office will be from the date of approval by this Board of Directors meeting until the expiration of the term of the Fifth Board of Directors.

According to the announcement, Wang Rui was born in 1962, is of Chinese nationality, and does not hold permanent residency rights overseas. He holds a bachelor's degree in pharmaceutical chemistry from Shanghai First Medical College (now Fudan University) and a master's degree in business management from Sun Yat-sen University. He is a senior engineer in pharmaceuticals. He previously served as the plant manager of Lizhu Pharmaceutical Factory under Livzon Group and as the chief engineer of Livzon Pharmaceutical Group Inc. With nearly 40 years of experience in the pharmaceutical industry, he is well-versed in production management, quality management, and engineering management in the pharmaceutical field. He has twice received the Second Prize of Guangdong Province’s Science and Technology Progress Award and was awarded the Special Prize for Outstanding Contribution to Science and Technology Progress in Zhuhai City in 1999. In 2015, he was recognized as a high-level talent in Zhuhai City. He joined our company in February 2023 as the Special Assistant to the General Manager and currently serves as the Vice General Manager of the company.

RemeGen Chief Financial Officer Resigns

On September 5, RemeGen announced that the board of directors received a written resignation letter from Li Jia, the company's Chief Financial Officer and Joint Company Secretary, on September 4, 2023. Due to personal career development reasons, Li Jia applied to resign from the positions of Chief Financial Officer and Joint Company Secretary, and will no longer hold any position in the company after the resignation. Li Jia’s resignation takes effect from the date when the written resignation letter was delivered to the board of directors, and the company’s finance department and securities & investment and financing departments will continue to perform their respective duties.

China's First Domestic CD22 Antibody Marketing Application Accepted

On September 5, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) announced that SinoMab Bioscience's subsidiary, SciClone Biotherapeutics, had submitted a new drug application for Sucriluzumab Injection, which has been accepted. Sucriluzumab is an anti-CD22 monoclonal antibody developed by SinoMab Bioscience and is also the first CD22 antibody in China, as well as the world’s first CD22 antibody for autoimmune diseases. Additionally, an application for marketing authorization for Sucriluzumab in treating rheumatoid arthritis was filed in August this year.

According to the information disclosed by China Antibody, compared with the existing standard therapies for rheumatoid arthritis, the core advantage of Sucrilumab lies in its novel and unique mechanism of action: it recruits relevant inhibitory molecules by altering the binding mode of CD22, thereby suppressing B-cell-related immune responses. Since it does not damage B cells, the drug does not affect the normal function of B cells in the immune system. This mechanism of action ensures that Sucrilumab is effective while offering significant advantages in terms of safety, which is a key concern for patients with autoimmune diseases requiring long-term medication.

Yuheng Bio's PD-1 antibody Zimberelimab approved for cervical cancer indication

Recently, Yuheng Bio announced that the second indication of its anti-tumor new drug, Yutu (Zimberelimab Injection, a fully human anti-PD-1 monoclonal antibody), has been approved for marketing by the National Medical Products Administration (NMPA) in China. It is indicated for patients with recurrent or metastatic cervical cancer who are PD-L1 positive (CPS≥1) and have failed prior platinum-based chemotherapy. Zimberelimab has thus become the first and only PD-1 antibody approved for cervical cancer indication in China.

Roland Meier Joins Sparx as Chief Medical Officer

On September 5, SparX Biopharmaceutical announced that Dr. Roland Meier has officially joined SparX Biopharmaceutical as Chief Medical Officer (CMO).

Meier is a medical and philosophy doctor from the University of Zurich and the University of Lausanne in Switzerland, and completed postdoctoral work at the University of California, Berkeley. He has over two decades of clinical development experience in innovative drugs, covering all stages from oncology drug discovery, marketing authorization to lifecycle management. In addition to an extensive track record including INDs, BLAs, and sBLAs, Meier has authored numerous professional papers, reviews, and patents. He has held medical leadership positions in almost all major international pharmaceutical companies, most recently serving as Chief Medical Officer at Kyowa Kirin and Vice President of the Immunology-Oncology division at Eli Lilly and Company.

Zenas BioPharma Reaches Strategic Licensing and Collaboration Agreement with Bristol-Myers Squibb

On September 5, Zenas BioPharma announced that it had entered into a licensing and collaboration agreement with Bristol Myers Squibb to develop and commercialize Obexelimab for the treatment of autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong, and Australia.

According to the terms of the license agreement, Zenas will receive an upfront cash payment of $50 million and is eligible for additional payments related to the achievement of certain development, regulatory, and commercial milestones, as well as royalties on net sales of Obexelimab in the licensed territory. In exchange, Bristol Myers Squibb will obtain exclusive rights to develop and commercialize Obexelimab in the licensed territory. Additionally, Bristol Myers Squibb is making an equity investment in Zenas.

Zai Lab's "Efgartigimod" Commercial Launch in China

Recently, Zai Lab's first self-immune drug "Efgartigimod" (brand name: Vyvgart) has officially been commercially launched in China. The first batch of prescriptions have been issued across the country, with a retail price of 10,300 RMB per bottle (400mg/20ml/bottle).

This product was introduced by Zai Lab in January 2021 from the Dutch biotech company Argenx, a rising star in autoimmune diseases. In June this year, Efgartigimod received approval from the National Medical Products Administration (NMPA) for marketing in China. It is to be used in combination with conventional therapies for the treatment of adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) antibodies.

Neurophth's Ophthalmic Gene Therapy New Drug Approved for Clinical Trial in Australia

On September 6, Neurophth announced that its candidate drug NFS-05, for the treatment of Autosomal Dominant Optic Atrophy (ADOA), completed clinical trial registration with the Australian Therapeutic Goods Administration (TGA) and has been approved to commence clinical trials.

Currently, there are no effective treatments for ADOA available in clinical practice. Neurophth's self-developed NFS-05 ophthalmic injection employs a gene therapy strategy, delivering an AAV vector carrying the OPA1 gene into the vitreous cavity. The viral vector infects RGC cells and expresses the OPA1 protein, thereby restoring mitochondrial function. It is reported that NFS-05 is the third new drug developed by Neurophth to be approved for clinical trials, and it marks the company’s first clinical approval in Australia.

Goserelin Microspheres Approved for New Indication in China, for the Treatment of Breast Cancer

On September 7, Luye Pharma Group and BeOne Medicines announced that the innovative formulation independently developed by Luye Pharma – injectable goserelin microspheres (BaiTuoWei) – has been approved by the China National Medical Products Administration for the treatment of breast cancer in premenopausal and perimenopausal women who are eligible for hormone therapy.

On June 30 this year, Bailtov was approved in China for the treatment of prostate cancer. Bailtov is the world's first and currently the only approved microsphere formulation of goserelin. Through innovative microsphere technology, it significantly improves the patient's medication experience while ensuring therapeutic efficacy and safety.

BeOne Medicines' LAG3 Monoclonal Antibody Approved for New Clinical Trials in China

On September 7, according to the CDE official website, the clinical trial application for LBL-007 Injection submitted by BeOne Medicines received tacit approval for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma (Acceptance No.: CXSL2300445).

Currently, LBL-007 has initiated a total of 7 clinical trials, involving not only esophageal squamous cell carcinoma but also NSCLC, colorectal cancer, and melanoma, which are in Phase II, Phase I/II, and Phase I clinical stages, respectively.

On December 14, 2021, BeOne Medicines acquired the LAG-3 antibody drug LBL-007 from Weilizhi Bo for $773 million.

Under the agreement, BeOne Medicines obtained global research and development and production licenses for LBL-007, as well as exclusive commercial rights outside of China. Meanwhile, HealZen Therapeutics received a $30 million upfront payment and potential milestone payments of up to $742 million related to R&D, regulatory, and sales milestones, along with tiered royalties in the double-digit percentages.

InflaRx Appoints David Topper as Chief Financial Officer

On September 7, Inmagene Biopharmaceuticals announced the appointment of David Topper as Chief Financial Officer.

Public information shows that David has approximately 40 years of experience in finance, management, investment, and investment banking. Before joining Inmagene, he was a partner at Frazier Life Sciences, an investment firm managing approximately $5 billion in assets. He also served as the Chief Financial Officer and director of Frazier Life Sciences Acquisition Corp, successfully leading the company’s merger with New Amsterdam Pharma. Additionally, David worked at Morgan Stanley for 22 years, where he held positions such as Managing Director, Co-Head of Global Equity Capital Markets, Executive Director, and Chairman of the Commitment Committee.

InxMed focuses on the development of novel drugs in the field of immunology and inflammatory diseases, with four drug candidates currently in clinical stages.

HealZen Therapeutics' BTK Inhibitor Proposed for Inclusion in Breakthrough Therapy Designation

On September 7, the CDE website announced that HealZen Therapeutics' application for the new drug HZ-A-018 capsule (Class 1) is proposed to be included in the breakthrough therapy designation, intended for the treatment of relapsed or refractory primary central nervous system lymphoma. Public information indicates that HZ-A-018 is an orally administered small molecule BTK inhibitor with high selectivity and strong blood-brain barrier permeability.

According to the China Drug Clinical Trial Registration and Information Public Platform, HealZen Therapeutics is conducting two clinical trials. One is a Phase 1/2 study evaluating the safety and efficacy of HZ-A-018 in treating relapsed or refractory primary or secondary central nervous system lymphoma, and the other is a Phase 1 clinical study assessing the safety, tolerability, and pharmacokinetic characteristics of HZ-A-018 in patients with B-cell lymphoma.

Capital Market

Tianjin Tongrentang Group Co., Ltd. ChiNext IPO Terminated

On September 7, the official website of the Shenzhen Stock Exchange announced that Tianjin Tongrentang Group Co., Ltd. (referred to as: Tianjin Tongrentang) had withdrawn its application for listing on the ChiNext Board, resulting in termination. Tianjin Tongrentang had chosen the listing standard specified in Item (1) of Chapter 2, Section 2.1.2 of the "Rules Governing the Listing of Stocks on the ChiNext Board of the Shenzhen Stock Exchange (Revised 2023)": The net profits for the last two years are both positive, with a cumulative net profit of no less than 50 million yuan.

The prospectus shows that Tianjin Tongrentang Group Co., Ltd. plans to raise 722 million yuan in this offering. Its main business is the research, development, production, and sales of traditional Chinese medicine. Its product range covers eight dosage forms, including tablets, hard capsules, granules, syrups, oral liquids, oral solutions, rubber plasters, and powders, involving treatment areas such as kidney diseases in the urinary system, cardiovascular and cerebrovascular diseases, and peripheral vascular diseases.

It is reported that Tianjin Tongrentang Group Co., Ltd. once applied for listing on the main board of the Shanghai Stock Exchange in 2018 and withdrew its application in December 2020.

PILOT Gene Technologies Secures Nearly RMB 100 Million in Series B Financing

Recently, PILOT Gene technologies (Hangzhou) Co., Ltd. has secured nearly 100 million yuan in a new round of financing. This round was led by Simiao Capital, with existing shareholders also increasing their investment. Xuejian Capital served as the exclusive financial advisor for this round. The funds will mainly be used for the development of fully automatic instruments and POCT equipment, subsequent production and sales of Class III reagent certificates, and the expansion of overseas business.

PILOT Gene Technologies raised 140 million yuan in its A+ round of financing in 2021. In 2022, PILOT Gene Technologies obtained multiple CE certificates for its digital PCR platforms and reagents, officially starting its expansion into overseas markets.

Sparx Completes RMB 250 Million Series B Financing

Recently, Shanghai Cota Biotechnology Co., Ltd. completed a B-round financing of 250 million RMB, jointly led by Hengxu Capital and Eight Roads Capital, with participation from Henan Huirong and Bits x Bites. Yuanqi Capital served as the exclusive financial advisor.

This round of financing also marks the fourth round completed by Create Biotech in nearly two years since its establishment, with a total of nearly 500 million yuan in funding reserves.

Cotyria Biotech was founded in September 2021 in Shanghai, China. The founder, Zhaoshan Zhao, has over 20 years of experience in synthetic biotechnology research and industrialization. He has led or participated in the development of several innovative technologies, including the creation of the world's first synthetic biology R&D platform, as well as the scaling and commercialization of more than ten new synthetic biology products.

Yiming Angke Biomedical Technology(Shanghai) Co., Ltd. Listed on HKEX

On September 5, Yiming Angke Biomedical Technology (Shanghai) Co., Ltd. was listed on the Main Board of the Hong Kong Stock Exchange, with an issue price of HK$18.6 per share. The closing price on the same day was HK$19.52 per share, a 4.95% increase on the first day, with a turnover of HK$18.66 million.

In this IPO, Yiming Angke Biomedical Technology(Shanghai) Co., Ltd. raised approximately 300 million Hong Kong dollars. Notably, its cornerstone investors include well-known funds and industry players such as Harvest Fund, Wuxi Biologics, RemeGen, and ClinChoice.

Yiming Angke Biomedical Technology(Shanghai) Co., Ltd. is a biotechnology company dedicated to developing cancer immunotherapies. It was founded by Tian Wenzhi on June 18, 2015, in Zhangjiang, Shanghai. Currently, Yiming Angke has developed a pipeline containing more than 10 innovative drug candidates and has seven ongoing clinical research projects. Among them, the most notable attention from outside is on the company's series of differentiated product portfolios targeting the CD47 pathway.

Hangzhou Sanofi Minsheng Consumer Healthcare Co., Ltd. Listed on SZSE

On September 5, Hangzhou Sanofi Minsheng Consumer Healthcare Co., Ltd. was listed on the Shenzhen Stock Exchange, planning to raise 465 million yuan. The funds will be used for the intelligent production line technical renovation project of OTC vitamin and mineral products, the intelligent production line technical renovation project of health foods, and the technical renovation project of the Minsheng Health Research and Development Center. Among these, the intelligent production line technical renovation project of health foods is expected to utilize 329 million yuan of the raised funds, accounting for over 70% of the total amount.

Minsheng Health was founded in 2009, focusing on the field of vitamins and mineral supplements. The well-known brand "21 Golden Vitamins" is its flagship product. In 2020, it acquired Zhejiang Minsheng Health Technology Co., Ltd., expanding its product portfolio to include probiotics. In the future, Minsheng Health may focus more on the dietary supplement sector.

Gravel Bio Completes RMB 400 Million Series B Financing

On September 8, Gravitec Bio announced the completion of a 400 million RMB Series B financing round, led by a fund under CICC Capital, with participation from Qianhai Ark, Liantong Investment, Yuanhe Capital, Hefangtian Partnership, and existing investors Sherpa Healthcare Partners, Decheng Capital, and Matrix Partners China.

This round of financing will be used to support the development of the company's Tumor Infiltrating Lymphocyte (TIL) therapy pipeline, including the pivotal clinical trials of GT101 and the development of multiple next-generation gene-edited TIL pipelines, aiming to create groundbreaking cell therapies for patients with solid tumors worldwide.

Grit Bio was founded in 2019 as an innovative pharmaceutical company focused on tumor immunotherapy and cell therapy, with a research pipeline represented by TIL drugs. GT101 Injection, independently developed by Grit Bio, is the first TIL drug approved for clinical registration in China and is about to enter the pivotal Phase II clinical trial.

Risk Warning

Latest Development in the Case of a Former NanoMicro Technology Employee Claiming 175 Million Yuan in Equity Incentives

On December 6 last year, NanoMicro Technology (SH.688690) announced that it had received a "Civil Complaint" and other related materials regarding a lawsuit filed by former employee Han Han against NanoMicro Technology, Suzhou Nabai Management Consulting Co., Ltd., and the company's chairman BIWANG JACK JIANG (Jiang Binwu), among three parties. According to NanoMicro Technology, this lawsuit is a dispute over the property share held by the former employee in the employee stock holding platform. The employee stock holding platform has reserved shares, and the company does not bear the obligation to repurchase incentive shares under the relevant incentive system arrangements, which will not have a significant impact on the normal operation of the company. However, being hit with a huge compensation lawsuit within less than two years of its IPO still raises concerns among investors.

Six months later, this case had not entered the trial stage until September 1, when NanoMicro Technology issued the "Announcement on the Progress of Litigation Involving Suzhou NanoMicro Technology Co., Ltd." The announcement stated that on August 31, 2023, the company received the "Complaint" and the "Second Application for Change of Litigation Claims" delivered by the Suzhou Intermediate People's Court. The litigation claims of the former employee, Mr. Han Han, were changed to: (1) Requesting the court to confirm that the plaintiff enjoys a property share of 4,230,240 yuan in Suzhou Nayan Management Consulting Partnership (Limited Partnership), held by the first defendant, Suzhou Nabei Management Consulting Co., Ltd., at a price of 38,273,600 yuan; (2) Ordering the first defendant, Suzhou Nabei, to pay the plaintiff the acquisition price of 122,909,330.28 yuan for 2,656,580 incentive shares and bear the loss of capital occupation; (3) The second defendant, BIWANG JACK JIANG, shall bear joint liability for the payment obligation of Suzhou Nabei; (4) The litigation costs and preservation fees of this case shall be jointly borne by the two defendants. Most importantly: the plaintiff changed the litigation claims. After the change, NanoMicro Technology is no longer the defendant in the case but participates as a third party. The plaintiff did not request NanoMicro Technology to assume responsibility as a third party.

"Compliance New Perspective" believes: Employee equity incentives are reward mechanisms designed to retain key talent. Business operators transfer partial rights to employees, forming a community of shared interests between employees and the company, thereby motivating employees. However, disputes over equity incentives often arise in startups with high employee turnover or newly listed companies. Properly handling labor relations and equity incentive relations before and after an employee's departure is crucial. An equity incentive plan that suits the company’s development stage, is reasonable, legal, and effectively implemented can prevent "incentives" from turning into "litigation." In this case, NanoMicro Technology has changed from being the defendant to a third party, likely due to significant terms in the contract playing a major role.

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