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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 10 July 2025 and 16 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 71 drug names.

2025/07/10 – 2025/07/16

Period
2025/07/10 to 2025/07/16, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
390
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
70

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

390filings, 107 of them generic

By application type

Application typeFilings
Supplement165
Generic107
New drug82
Import22
Import re-registration13
Unspecified1

By drug type

Drug typeFilings
Chemical drug258
TCM76
Therapeutic biologic52
Prophylactic biologic3
Biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

71 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Empagliflozin Tablets4218
3Minoxidil Liniment4252
4Guanfacine Hydrochloride Extended Release Tablets414
5Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
6Acetylcysteine Injection2253
7Baricitinib Tablets2232
8瑞维那新吸入溶液 · No verified English name2253
9Nicardipine Hydrochloride Injection2213
10维生素K1滴剂 · No verified English name223

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

229 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized1290
2Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized12612
3Jiangxi Qing Feng Pharma Co., Ltd. romanized880
4AstraZeneca AB630
5Janssen-Cilag International NV630
6Bracco Imaging S.P.A.610
7Eli Lilly and Company610
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
9Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.432
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

151 this week

AcceptedDrugApplicants
2025/07/16Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500103 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/16Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500102 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502556 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502555 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502554 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2502553 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized
2025/07/16Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2502552 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized
2025/07/16Generic · Class 3 多种微量元素注射液(4-Ⅱ) · No verified English nameCYHS2502551 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/07/16Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502550 Qingdao Rui Nai Medical Technology Co., Ltd. romanized
2025/07/16Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502549 Qingdao Rui Nai Medical Technology Co., Ltd. romanized
2025/07/16Generic · Class 3 Furosemide Oral SolutionCYHS2502546 Zhengzhou Da Ruo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/07/16Generic · Class 3 Cimetidine InjectionCYHS2502539 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/16Generic · Class 3 维生素K1滴剂 · No verified English nameCYHS2502535 Zhejiang Wei Kang Pharma Co., Ltd. romanized
2025/07/16Generic · Class 3 维生素K1滴剂 · No verified English nameCYHS2502534 Kui Hua Pharma Group (Xiang Yang) Long Zhong Co., Ltd. romanized
2025/07/16New drug · Class 3.1 宣郁通经汤颗粒 · No verified English nameCXZS2500030 Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized
2025/07/16New drug · Class 1 HS_SW01细胞注射液 · No verified English nameCXSL2500598 Shenzhen Hui Shan Bio Technology Co., Ltd. romanized
2025/07/16New drug · Class 1 HS_SW01细胞注射液 · No verified English nameCXSL2500597 Shenzhen Hui Shan Bio Technology Co., Ltd. romanized
2025/07/16New drug · Class 1 TJ101注射液 · No verified English nameCXSL2500596 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2025/07/16New drug · Class 1 HX044注射液 · No verified English nameCXSL2500595 Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2025/07/16New drug · Class 2.2 ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2500594 Shanghai Rui Zhou Bio Technology Co., Ltd. romanized; Shanghai Wei Zhou Bio Technology Co., Ltd. romanized; Changchun Rui Zhou Biopharmaceutical Co., Ltd. romanized
2025/07/16New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500083 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/07/16New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500082 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/07/16New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500081 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/07/16New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500080 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/07/16New drug · Class 1 IBI3032 · No verified English nameCXHL2500702 Xin Da Bio Technology Co., Ltd. romanized
2025/07/16New drug · Class 1 IBI3032 · No verified English nameCXHL2500701 Xin Da Bio Technology Co., Ltd. romanized
2025/07/16New drug · Class 1 IBI3032 · No verified English nameCXHL2500700 Xin Da Bio Technology Co., Ltd. romanized
2025/07/16New drug · Class 1 IBI3032 · No verified English nameCXHL2500699 Xin Da Bio Technology Co., Ltd. romanized
2025/07/15Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2502531 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/07/15Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2502529 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized

121 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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