Zhangjiang Adds One New Class 1 Drug in May Amid Surge in Financing and BD Deals
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
RemeGen
Biological New Drug Developer
Allist Pharmaceuticals
Innovative Drug Developer
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Wave after wave of dreamers with new drug aspirations, armed with ideas and experience, have stepped out from research institutes and large multinational platforms to start from scratch in Zhangjiang Pharm Valley. Relying on "innovation," they have turned the "cold bench" of China's innovative drug market into a hot seat. Zhangjiang Pharm Valley has made China's innovative drug dream a reality.
As a companion to entrepreneurs in the pharmaceutical industry on their dream-chasing journey, Yao Gu Jun launches a fixed column "Monthly Industry Report" every month, looking back at the hot trends in the life science industry and Zhangjiang Pharma Park enterprises over the past month, witnessing every step of their development.
Policy Orientation
● Notice of the General Office of the National Medical Products Administration on the Implementation of the "Quality Management Standard for Medical Device Online Sales"
On May 26, in order to further strengthen the quality and safety supervision of online medical device sales, standardize online medical device sales behavior, and ensure public safety in the use of medical devices, the National Medical Products Administration issued the "Quality Management Standard for Online Sales of Medical Devices" (Announcement No. 46 of 2025, hereinafter referred to as the "Standard"), which will officially come into effect on October 1, 2025. The introduction of the "Standard" is of great significance in guiding enterprises and e-commerce platforms to enhance the quality management of online medical device sales, standardizing online medical device sales behavior, and ensuring the quality and safety of medical devices sold online.
●Announcement of the National Medical Products Administration on the Release of the "Regulations for the Management of Experimental Research on Narcotic Drugs and Psychotropic Substances"
On May 29, in order to further strengthen the supervision and management of experimental research on narcotic drugs and psychotropic substances, based on laws and regulations such as the "Drug Administration Law of the People's Republic of China" and the "Regulations on Narcotic Drugs and Psychotropic Substances," the National Medical Products Administration has organized the revision of the "Regulations on the Management of Experimental Research on Narcotic Drugs and Psychotropic Substances," which is hereby announced and will be implemented from the date of issuance.
Major Progress
May 9,Hansoh PharmaAnnounce, Aumetinib Mesylate Tablets (Trade Name: Almela)®) New indication approved by NMPA for marketing, indicated for the treatment of adult patients with stage II-III B non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
May 9,RemeGenAnnounced, the original ADC drug Disitamab Vedotin (trade name: Aidixi)®) has been approved by the NMPA for marketing, indicated for HER2-positive patients with advanced breast cancer who have previously received trastuzumab or its biosimilars and taxane-based therapies, and have liver metastases.
May 22,Allist PharmaceuticalsAnnounce, KRAS G12C inhibitor Geforantib citrate tablets (trade name: Arike)®) has been approved by the NMPA for marketing, indicated for adult patients with advanced non-small cell lung cancer harboring KRAS G12C mutations who have received at least one prior systemic therapy.
May 29,Genor BiopharmaAnnounced that the NDA for Lerociclib (GB491) has been approved by the NMPA., applicable to adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) locally advanced or metastatic breast cancer; used in combination with aromatase inhibitors as initial endocrine therapy, and combined with fulvestrant for patients whose disease has progressed after prior endocrine therapy.
Project Progress
May 8,Roche Pharmaceuticals China New Biopharmaceutical Production Base Investment Project Launch CeremonyHeld at the Zhangjiang Science Hall. The project investment reaches 2.04 billion yuan, and the first-phase products will mainly be used for the localized production of treatments for patients with fundus diseases, accelerating the fulfillment of Chinese patients' demand for high-quality medications.
May 23-26,2025 DIA Drug Information Conference and ExhibitionHeld at the Zhangjiang Science Hall. Under the theme of "Gathering Global Wisdom to Lead Pharmaceutical Innovation," the conference brought together representatives from global pharmaceutical regulatory agencies, research scholars, and industry leaders to discuss international cooperation and innovation in the biopharmaceutical field. With the active promotion of the Shanghai Municipal Science and Technology Commission and the efforts of all parties, the DIA Shanghai Office has settled in the Shanghai Qiantan International Economic Organization Cluster this month.
Enterprise Honors
On May 8, TIME magazine unveiled the 2025 TIME100 Most Influential People in Health list.Akeso BiopharmaDr. Xia Yu, Founder, Chairman, President and CEO, has been selected for the list and is featured in the "Titans" category of this year’s ranking.
On May 10, the 6th Shanghai Innovation and Entrepreneurship Young 50 Forum was successfully held.Forward BiologyAwarded the Innovation Potential Award at the Shanghai Youth Science and Technology Innovation Carnival Roadshow Project.
On May 15, the Global Cardiovascular Congress announced the series of awards for global cardiovascular medical technology innovation.NuPulse MedicalThe self-developed Prizvalve Transcatheter Aortic Valve System won the "2025 Global Cardiovascular Technology Innovation Award".
On May 16, the 2025 Fortune China ESG Impact List was released.Fosun PharmaBecoming the only Chinese pharmaceutical company selected for the list.
HenliusUpgrade to ISO/IEC 27001: 2022 Information Security Management System (ISMS) certification, and obtain accreditation marks from CNAS (China National Accreditation Service for Conformity Assessment), ANAB (ANSI National Accreditation Board), and UKAS (United Kingdom Accreditation Service).
Capital Dynamics
May 9,Jingyin PharmaceuticalsAnnounced the completion of a nearly 50 million USD Series B2 financing round, led by a globally renowned industry investment institution, with participation from Boyuan Capital, Orbimed, Hongyuan Capital, and Hansoh Capital. The proceeds will be used to further advance the clinical pipeline and expand the product portfolio, aiming to accelerate the development of groundbreaking siRNA therapies for chronic disease prevention and treatment, benefiting patients worldwide.
May 10,XtalPi Holdings(Our wholly-owned subsidiary, the buyer), Shanghai Siwei Medical Technology Co., Ltd. (the seller), the guarantor, and Siwei Medical entered into an agreement pursuant to which Jingtai Holdings has conditionally agreed to purchase, and Siwei Medical (Seller 1, Seller 2, and Seller 3, holding 59.11%, 16.89%, and 14.00% equity respectively, all held by Hongsheng Capital) has conditionally agreed to sell 90% of Siwei Medical’s equity for a consideration of RMB 250 million, to be settled in full by cash.
May 20,KeyStone PharmaceuticalsAnnounced the completion of the full B+ round of financing exceeding 100 million yuan, funded by Yueke Mother Fund. The proceeds will be mainly used to advance the Phase III clinical development of the core product CG-0255 in the cardiovascular and cerebrovascular fields.
Baiyi Yuan BioCompleted tens of millions of yuan in financing, exclusively invested by Kangzhe Pharmaceuticals. The funds raised will mainly be used for new product research and development, market expansion, and production line upgrades.
AuoTechCompleted a nearly RMB 100 million Series B++ round of financing, jointly invested by Infiniti Capital, Zhejiang Development Asset Management Co., Ltd. under Zhejiang Provincial State Capital Operation Co., Ltd., and Vantage Capital. The proceeds will be mainly used to accelerate continuous R&D breakthroughs in the dexterous hand technology field, promote the launch process of the new generation of dexterous hand products, expedite the market entry of finger joint exoskeleton robots, and help the company establish an internationally leading standardized production system, optimize production processes, and achieve a 100% increase in annual production capacity.
Boin BiotechCompleted tens of millions of yuan in angel+ round financing, led by Zhangjiang Life Health Industry Incubation Angel Fund ("Zhangke He Miao Fund"), with continued investment from existing shareholder Fengrui Capital and the founder personally. The funds raised will be mainly used for advancing the company’s product pipeline and early clinical validation of the first product, as well as supporting the iteration of the company’s technology platform.
Heartlight BiopharmaCompleted the Pre-A++ round of financing, invested by Xingfu Capital. The funds raised will be mainly used to accelerate the mass production and registration of its self-developed portable dialysis machine.
Pharmaceutical Transactions
May 9,Minghui PharmaceuticalsAnnounced that it has reached an agreement withQilu PharmaceuticalAn exclusive license and cooperation agreement has been reached to develop, manufacture, and commercialize its B7-H3 ADC (MHB088C) in China (including Hong Kong, Macao, and Taiwan regions). According to the agreement, Qilu Pharmaceutical will obtain exclusive rights to MHB088C in the aforementioned regions, while Minghui Pharmaceuticals is expected to receive total payments of up to 1.345 billion yuan, including an upfront payment and near-term milestone payments of 280 million yuan, development, regulatory, and sales milestone payments totaling 1.065 billion yuan, as well as net product sales royalties in the double-digit range. Minghui Pharmaceuticals will retain global rights to MHB088C outside of China (including Hong Kong, Macao, and Taiwan regions) and continue to advance development efforts in these areas.
May 20,3SBioAnnounce that the company and its related parties, 3SBio and Shenyang 3SBio Pharmaceutical Co., Ltd., have jointly grantedPfizerThe exclusive rights for the development, production, and commercialization of PD-1/VEGF bispecific antibody SSGJ-707 worldwide (excluding mainland China). Pfizer retains the right to obtain a commercial license for the product in mainland China by making an additional payment.
May 20,Jingyin PharmaceuticalsJingyin Pharma and CRISPR Therapeutics announced a strategic partnership to jointly advance the co-development and commercialization of siRNA therapies. The collaboration will focus on developing and commercializing SRSD107, a next-generation long-acting FXI-targeted siRNA therapy for treating thrombotic and thromboembolic diseases. Under the terms of the agreement, Jingyin Pharma will receive $95 million in cash and cash equivalents as an upfront payment from CRISPR and is eligible to receive over $800 million in upfront and milestone payments. Both parties will co-develop SRSD107 under a 50-50 cost and profit-sharing mechanism. Additionally, the agreement grants CRISPR exclusive rights to prioritize licensing for up to two additional siRNA projects in the future.
May 27,EpimAb BiotherapeuticsAnnouncement of a Global Licensing Agreement with TCG Labs Soleil Portfolio Company Juri Biosciences. The agreement grants Juri Biosciences global exclusive rights to develop T-cell engaging molecules targeting Kallikrein-related peptidase 2 (KLK2) and CD3 for the treatment of metastatic prostate cancer. Under the terms of the agreement, EpimAb Biotherapeutics is entitled to receive up to $210 million, including an upfront payment, and development, regulatory, and commercial milestone payments, as well as royalties.
May 30,CynovaHua An and Astellas Pharma announced that they have reached an exclusive licensing agreement for XNW27011, a next-generation ADC drug targeting CLDN18.2 that is currently in the clinical stage. Under the agreement, Astellas is granted exclusive rights to develop and commercialize XNW27011 globally (excluding mainland China, Hong Kong, Macao, and Taiwan). According to the terms of the agreement, Sinovant will receive an upfront payment of $130 million and is eligible to receive near-term payments of up to $70 million, as well as milestone payments related to development, registration, and commercialization totaling up to $1.34 billion. Additionally, after XNW27011 is approved and launched, Sinovant will also receive royalties based on the product's net sales.
Yifan PharmaceuticalHolding SubsidiaryEvive BiotechEntered into a cooperation agreement with LENIS farmacevtika d.o.o. ("LENIS"), under which Eternity Bio will provide the novel biologic drug Efbegestim Alfa Injection (Chinese trade name: Yilishu).®, English trade name: Ryzneuta®) The exclusive distribution rights in 8 Eastern European countries are licensed to LENIS, and LENIS is responsible for Ryzneuta.®Market planning and sales in eight Eastern European countries. According to the agreement, Eternity Bio will generate international revenue by selling products to LENIS and receive an upfront payment and milestone payments from LENIS. LENIS will be responsible for product pricing, reimbursement, marketing, distribution, and related matters, and will purchase products from Eternity Bio as stipulated in the agreement. Eternity Bio will be responsible for supplying the products and providing necessary training and support for the relevant brands.
(Edited by the Yaogu team)