On March 30, 2020 Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, reported that Hunter Smith, the Company’s Chief Financial Officer, has been named to the additional role of Interim Chief Executive Officer, effective immediately (Press release, Rhythm Pharmaceuticals, MAR 30, 2020, View Source [SID1234556041]). Mr. Smith succeeds Keith Gottesdiener, M.D. whose planned departure was announced by the Company in January 2020. Dr. Gottesdiener stepped down from his roles as CEO, President and member of the Board of Directors following the Company’s completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"On behalf of the Board, I am pleased that Hunter and the Rhythm management team will continue their excellent stewardship of the Company and dedication to transforming the care of people living with rare genetic disorders of obesity while we continue our search for a permanent CEO," said David Meeker, M.D., Chairman of the Board of Directors. "With Murray Stewart, Chief Medical Officer, leading our clinical development and regulatory strategy and Nithya Desikan, Chief Commercial Officer, and her team making tremendous strides in community building, we believe that Rhythm is well positioned to change the paradigm for rare genetic obesity."

As previously disclosed, the Company’s Board of Directors has formed a search committee and retained an executive search firm to assist in identifying Dr. Gottesdiener’s permanent successor. The Board has made significant progress in the search process and is considering a number of highly qualified candidates.

"I look forward to working closely with the Board, Murray and Nithya, our colleagues on the management team, and the entire Rhythm team to advance setmelanotide," Mr. Smith said. "We are committed to working with patients and the community to build greater awareness and understanding of rare genetic disorders of obesity so we can maximize our impact and transform the care of people living with these conditions."

COVID-19 and Business Continuity
To help protect the health and safety of the patients, caregivers and healthcare professionals involved in its ongoing clinical trials of setmelanotide, as well as its employees, in response to the novel coronavirus (COVID-19) pandemic, Rhythm has implemented a number of precautionary clinical and operational measures to protect patient well-being and ensure consistent and appropriate clinical trial conduct.

With many clinical trial sites already closing down in response to COVID-19-related country- and state-level guidelines and more closures expected, Rhythm and study investigators and staff remain focused on the safety, treatment and monitoring of patients currently enrolled in these trials. Rhythm has introduced measures to ensure patients in ongoing clinical trials continue to be monitored as scheduled and receive their study drug.

Mr. Smith continued, "We are acutely aware of the unprecedented crisis unfolding across the globe as a result of the COVID-19 pandemic. Over the past several weeks, we have put measures in place to protect the health and safety of patients and staff participating in our clinical trials, as well as our employees and their families, and to seek to ensure that our ongoing studies can continue with minimal interruption."

POMC Deficiency Obesity and LEPR Deficiency Obesity
Today, Rhythm announced that it has completed its rolling submission of an NDA to the FDA for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. The FDA typically has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Rhythm has requested priority review for the application which, if granted, could provide a target FDA review period of six months from the application filing date. Rhythm continues to anticipate that it will submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second quarter of 2020. At this time, Rhythm is continuing its regular interactions with the FDA and EMA and based on current information, the Company does not anticipate COVID-19 to materially affect its timelines.

Ongoing Clinical Trials of Setmelanotide
Rhythm continues to expect to meet disclosed timelines for reporting data from its pivotal Phase 3 trial in Bardet-Biedl Syndrome (BBS) and Alström Syndrome and Phase 2 Basket Study. The Company anticipates announcing topline data in the fourth quarter of 2020 or early in the first quarter of 2021 from the Phase 3 BBS and Alström syndrome trial, which completed enrollment in December 2019. Rhythm also anticipates announcing additional data in high-impact heterozygous (HET) obesity and additional data from one or more of its other ongoing indications in 2020, based on current enrollment levels in the Phase 2 Basket Study.

Rhythm currently believes there will be no disruption of clinical supply of setmelanotide. The Company’s contract manufacturers have indicated that they have appropriate plans and procedures in place to ensure uninterrupted future supply of clinical and commercial-grade setmelanotide, subject to potential limitations on their operations due to COVID-19.

Corporate Operations

Consistent with guidelines from the Centers for Disease Control (CDC) and the Commonwealth of Massachusetts, Rhythm has also implemented measures to help keep the Company’s employees, families, and local communities healthy and safe. All employees are working remotely and all business travel has been restricted.

On March 30 2020 I-Mab (the "Company")(Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported a strategic partnership with Kalbe Genexine Biologics ("KG Bio"), a joint venture of Kalbe Farma Tbk ("Kalbe"), and Genexine, Inc. ("Genexine") (Press release, I-Mab Biopharma, MAR 30, 2020, View Source [SID1234556023]). Under the terms of the agreement, KG Bio will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab discovered product candidates: TJD5, a highly differentiated anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With the agreement, KG Bio will have a right of first negotiation for exclusive rights to commercialize these two product candidates in the ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) and MENA (Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates, Palestine, and Yemen) regions, as well as Sri Lanka.

"This partnership recognizes the potential of our internally-discovered anti-CD73 antibody TJD5 in immuno-oncology, and its clear clinical differentiation related to a novel epitope of CD73," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "We are pleased to enter into this strategic partnership with the Kalbe corporate family, which is a leader in commercializing innovative therapies in Southeast Asia and other key strategic markets and deepen our relationship with Genexine. We believe this partnership will expand the commercialization potential of TJD5 and other candidates in our portfolio."

"I-Mab has a highly innovative and globally competitive pipeline epitomized by products with best-in-class potential such as TJD5. With this novel partnership KG Bio will further strengthen its immuno-oncology portfolio. We are determined to maximize the potential of these products by leveraging our commercial capabilities and presence in the ASEAN, Middle East and North Africa (MENA) regions as well as Sri Lanka, where demand for breakthrough therapies is growing significantly." commented Sie Djohan, President Director of KG Bio.

If and when I-Mab and KG Bio enter into the definitive licensing agreement for TJD5, I-Mab would be eligible to receive from KG Bio an aggregate amount of up to approximately $340 million, including an upfront payment and subsequent payments conditional upon achieving certain development

and commercial milestones. KG Bio would pay I-Mab tiered royalties in the low to mid-teen percentages on net sales from the ASEAN and MENA regions, as well as Sri Lanka.

About TJD5

TJD5 is a differentiated, humanized monoclonal antibody against CD73. CD73 is expressed in tumors and plays a critical role in suppressing immune cells in tumor micro-environment. By binding to a novel epitope and inhibiting CD73, TJD5 is believed to reshape the immuno-suppressive tumor micro-environment and increase T-cell anti-tumor activity. When combined with a PD-L1 antibody in vivo, TJD5 achieved better anti-tumor efficacy. TJD5 is currently being evaluated in a Phase 1, dose-escalation clinical trial in patients with advanced solid tumors in the United States.

About Kalbe Genexine Biologics (KG Bio)

KG Bio is a joint venture between Kalbe Farma of Indonesia and Genexine of South Korea. KG bio is focused on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Through innovative technological platform that ensures affordable and high-quality products, KG Bio aims to provide innovative biologic and immuno-oncology products, and better solutions in treating human diseases.

On March 30, 2020 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that the Board has the intention to carry out a rights issue of approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAR 30, 2020, View Source [SID1234556018]). An extraordinary general meeting will be held around May 5, 2020 (the "EGM") where the EGM is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof. The EGM is also proposed to resolve to authorize the Board of Directors to resolve on a directed share issue, corresponding to approximately SEK 30 million, with deviation from the shareholders’ preferential rights (the "Over-Allotment Option"), in order to meet potential additional demand from strategic investors and thereby broaden the shareholder base. The notice to the EGM will be announced through a separate press release. The Rights Issue and the potential Over-Allotment Option will require the Company’s articles of association to be amended by the EGM in respect of the level of share capital and number of shares that can be issued.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the US, Canada, Japan, Australia, Hong Kong, New Zeeland or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

Summary

The Board of Directors announces its intention to carry out the Rights Issue and the potential Over-Allotment Option (provided that the Rights Issue is oversubscribed). An EGM scheduled to be held around May 5, 2020, that will be announced through a separate press release, is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof and the potential Over-Allotment Option (as a directed share issue).
The Rights Issue and the potential Over-Allotment Option will require that the EGM resolves on amendments of the articles of association of the Company in respect of the level of share capital and number of shares that can be issued (which will be announced in the notice to the EGM).
The net proceeds from the Rights Issue and the potential Over-Allotment Option will be used to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes.
Subject to the EGM’s resolutions, the Rights Issue is fully guaranteed, including commitments from members of the Board of Directors and Management team to subscribe for their pro rata shares amounting to SEK 0.8 million, as well as guarantee commitments from existing shareholders and non-shareholders, including the Chairman of the Board, Pär-Ola Mannefred (through Aktiebolaget Äpplet).
The potential Over-Allotment Option will be conditional upon the Rights Issue being oversubscribed.
The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.
Isofol’s CEO Ulf Jungnelius comments: "Strengthening our cash position will secure the recruitment of patients for the Phase III AGENT trial and to maintain critical activities to maintain our recruitment pace. We currently have over 260 patients included and with maintained recruitment rate we expect to have 440 patients recruited by the fourth quarter. The COVID-19 pandemic may have an impact on our program and the company needs to use the proceeds of the capital raise to secure our clinical program and as the FDA has indicted, amend study protocols in light of the new circumstances pertaining to clinical development. Furthermore, we are also working to secure a commercial partner in Japan during 2020. I look forward to continuing the development of arfolitixorin with the clear goal to launch the drug globally during 2023."

Background and intention

Isofol is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival.

Arfolitixorin – the key active metabolite of widely used folate-based drugs – can potentially benefit all patients with advanced colorectal cancer as it does not require complicated metabolic activation to become effective. Arfolitixorin is currently being studied in the global Phase III trial, AGENT.

The Phase III AGENT trial is a randomized, controlled, multi-center study assessing the efficacy and safety of arfolitixorin, [6R]-5, 10-methylene-tetrahydrofolic acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), a number of curative metastasis resections, safety and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. The study is designed to show superiority of arfolitixorin over leucovorin.

The AGENT study is ongoing at approximately 80 sites in the U.S., Canada, Europe, Australia and recently also Japan, where the trial is planned to start in up to 15 clinics.

Isofol raised SEK 430 million in April 2017 through an initial public offering (the "IPO") focused on the funding of the Phase III AGENT study for its lead drug candidate arfolitixorin. The study targets 440 patients to receive first line treatment for metastatic colorectal cancer and has an adaptive design, meaning that there is an option to, based on an interim analysis of 330 patients, increase the sample with an additional 220 patients. The potential upsizing in number of patients was not funded at the time of the IPO. Some limited additional activities were included in the stated use of proceeds, including a few limited studies intended to support arfolitixorin’s path toward market authorization, some lean business development activities as well as general corporate purposes.

However, at the time of the IPO, the Phase III AGENT study was only an outline and after a 5-month regulatory process, the U.S Food and Drug Administration (the "FDA") concluded, after an SPA-process, that Avastin was required as a part of the study arms to reflect USA-approved standard of care. The consequences of this decision were not taken into account in the use of proceeds of the IPO.

Furthermore, the Phase III AGENT study has taken longer to recruit (3 months delay) with significantly higher costs pertaining to Avastin and the approval of Avastin biosimilars in the US and Canada. Thus, Isofol has asked the FDA to approve the use of Avastin biosimilars in the protocol which was accepted by FDA as long as the study protocol was amended. The amendment process is ongoing which has led to higher CRO costs, increases in costs per patient as well as regulatory & IPR-related costs.

Additionally, Isofol has expanded the scope of some of the additional studies to enhance the safety database and gene expression analyses of folate relevant genes that were not included in the original budget at the time of the IPO.

The Board of Directors intends to carry out the Rights Issue and the potential Over-Allotment Option to ensure the continued and successful development of the Company, in accordance with its business plan and strategy. The intention of the Rights Issue and the potential Over-Allotment Option is primarily to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes. Through the potential Over-Allotment Option, if exercised in full, the Company will receive an additional financing of approximately SEK 30 million before transaction costs. The potential Over-Allotment Option is conditional upon the Rights Issue being oversubscribed.

Isofol believes the planned interim analysis will be a major inflexion point. One outcome from this analysis is that the independent Data and Safety Monitoring Board will recommend that an additional 220 patients are recruited in order to achieve statistical significance. In such a scenario, additional financing will have to be secured to fund an additional 220 patients at an estimated cost of SEK 150 million. In addition to this, Isofol estimates an additional funding requirement of SEK 150 million to take the Company to market authorization.

Subscription undertakings and guarantee commitments

The Rights Issue is fully guaranteed through subscription and guarantee commitments.

A number of investors, including the Chairman of the Board, Pär-Ola Mannefred (who through Aktiebolaget Äpplet has provided a guarantee commitment corresponding to SEK 1 million), have provided guarantee commitments, which together with subscription undertakings from certain members of the Board of Directors and Management, represent SEK 150 million.

In addition, certain shareholders including Handelsbanken Fonder and Swedbank Robur have expressed that they are positive to the Rights Issue and that they intend to subscribe for their pro rata shares.

The Fourth Swedish National Pension Fund ("AP4") has expressed its intention to apply for subscription of shares in the Rights Issue corresponding to up to approximately 3 percent of the total number of shares in the Company following the Rights Issue. AP4 does not hold any shares in the Company today.

Members of the Board of Directors and Management, comprising Ulf Jungnelius, Pär-Ola Mannefred, Gustaf Albèrt, Sven Erickson and Robert Marchesani, who hold approximately 0.5 percent of the Company’s outstanding shares have committed to subscribe their pro rata shares in the Rights Issue amounting to approximately SEK 0.8 million.

EGM and expected timetable for the Rights Issue

The Board of Directors convene the shareholders to the EGM through a separate press release and the EGM will take place around May 5, 2020. A detailed timetable and terms of the Rights Issue will be announced if the Board of Directors resolves on the Rights Issue. The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Baker McKenzie acts as legal adviser to the Joint Bookrunners.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU) No 596/2014. The information was submitted for publication through the agency of the Company’s CEO at 08:00 CET on March 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On March 30, 2020 ImaginAb Inc., a leading clinical stage immuno-oncology imaging company, reported it has signed a multi-year non-exclusive license agreement with AstraZeneca (Press release, ImaginAb, MAR 30, 2020, View Source [SID1234556017]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, ImaginAb’s CD8 ImmunoPET technology will be used in AstraZeneca’s clinical trials in North America and Europe to facilitate clinical development of AstraZeneca’s novel immunotherapies and to advance the clinical utility of ImaginAb’s CD8 ImmunoPET.

The deal is an opportunity for ImaginAb to support AstraZeneca’s project teams on imaging CD8 cells in patients and both teams will be committed to analysing and interpreting the data for their respective research and development activities.

ImaginAb will receive license fees and other contingent payments.

This agreement follows the recently signed pre-competitive alliance between AstraZeneca, ImaginAb and other global pharmaceutical companies, announced on October 14, 2019.

Commenting on the news, Ian Wilson, Chief Executive Officer of ImaginAb said: "We are very pleased that AstraZeneca is expanding our relationship. Under the new agreement, ImaginAb will provide AstraZeneca with clinical doses of ImaginAb’s CD8 ImmunoPET minibody, as well as technical support, to AstraZeneca clinical trials involving novel immunotherapies. ImaginAb’s CD8 ImmunoPET technology is the clinically most advanced CD8 PET tracer. It is a powerful diagnostic approach for measuring non-invasively the effect of immunotherapies, which we believe will ultimately be used to predict therapeutic efficacy."

On March 30, 2020 Alphamab Oncology (stock code: 9966HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has established strategic partnership with Simcere and 3D Medicines (Beijing) Co., Ltd. ("3DMed") to advance the development and commercialization of KN035 (also known as envafolimab), a checkpoint inhibitor for programmed cell death ligand-1 (PD-L1), for oncology indications in mainland China (Press release, Alphamab, MAR 30, 2020, View Source [SID1234556016]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Alphamab Oncology is the exclusive manufacturer of KN035 and responsible for the production and supply of KN035. 3DMed will oversee KN035’s clinical development, registration and commercialization. Simcere will exclusively market KN035 in mainland China upon the product’s registration, and charge a marketing fee to 3DMed.

Invented by Alphamab Oncology, KN035 is a recombinant anti-PD-L1 single domain antibody fused with human Fc. In 2016, Alphamab Oncology and 3DMed reached an agreement to co-develop KN035 which is on track to be the first subcutaneous injectable anti-PD1/PD-L1 antibody to be approved globally. Compared to other marketed PD1/PD-L1 antibodies, KN035 has demonstrated distinctive advantages in safety, convenience and patient compliance, which may further improve patients’ quality of life. KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, with more than 900 patients enrolled, including a pivotal Phase II clinical trial investigating the treatment of advanced solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR). Additionally, KN035 is undergoing pivotal Phase III clinical trials for advanced biliary tract cancer (BTC) in China. On January 18, 2020, KN035 was granted FDA Orphan Drug Designation (ODD) for the treatment of advanced biliary tract cancer (BTC).

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology, commented, "KN035 is likely the first PD-L1 inhibitor with subcutaneous administration to be approved globally. Compared to PD-1/PD-L1 drugs on the market currently, it has strong differentiation and advantages including stability, compliance, convenience and cost. KN035 is one of our many globally competitive innovative candidates as a result of our relentless R&D effort by focusing on globally innovative biologics for over a decade. To certain extent, this also represents the trend that Chinese pharmaceutical companies are becoming more competitive in global innovation. And this collaboration amongst three companies not only has demonstrated how top tier innovative R&D, clinical and commercial teams in China join forces, but also could set the example of an outstanding collaboration of innovative drug R&D and commercialization in China aiming to benefit more cancer patients in the near future."

Mr. Jinsheng REN, Founder and Chairman of Simcere, added: "KN035 is a first-in-class single domain PD-L1 antibody. With distinctive characteristics and advantages such as subcutaneous injection and stability at room temperature, KN035 can improve compliance and the quality of life of cancer patients, and simultaneously may reduce medical costs and improve drug accessibility. It is a medication with greater clinical significance and can truly benefit patients and our society. This strategic partnership will enable synergy in early stage development, clinical development, and commercialization. Together, we hope to fulfill our mission of making better medicines available to patients sooner."

Dr. Zhaolong GONG, Chairman and CEO of 3DMed added, "We are pleased to reach a major partnership with Simcere, a company with a well-established marketing network and in-depth experience in the China market, to drive the development and commercialization of KN035 in oncology. In addition to the indications being investigated, we will fully leverage KN035’s distinctive differentiation advantages in convenience and safety features, by pursuing clinical development of KN035 in the first line treatment of advanced stage cancer, in maintenance therapy, in adjuvant and neo-adjuvant treatment, with the aim of providing better treatment options for cancer patients worldwide."