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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 12 February 2025 and 18 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 68 drug names.

2025/02/12 – 2025/02/18

Period
2025/02/12 to 2025/02/18, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
16

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

290filings, 95 of them generic

By application type

Application typeFilings
Supplement123
Generic95
New drug51
Import13
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug200
Therapeutic biologic55
TCM30
Prophylactic biologic3
Biologic2

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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets5327
2Nitroglycerin Injection427
3Esomeprazole Magnesium for Delayed-release Oral Suspension424
4Potassium Phosphates Injection222
5Polymyxin B sulfate for Injection226
6Diclofenac Sodium Sustained Release Tablets2110
7Oxcarbazepine Tablets214
8Ornidazole Injection210
9Brexpiprazole Tablets2131
10Bumetanide Injection2113

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

183 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV1240
2Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized870
3Henan Ying Feng Pharmaceuticals Co., Ltd. romanized840
4Hua Chuan Pharmaceutical Co., Ltd. romanized540
5CSPC OUYI PHARMACEUTICAL CO., LTD.523
6Novo Nordisk A/S510
7Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized432
8Jiangsu Vanguard Pharmaceutical Co., Ltd.424
9Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized424
10Xian Li Bang Pharmaceutical Co., Ltd. romanized410

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

110 this week

AcceptedDrugApplicants
2025/02/18Generic · Class 3 Lansoprazole For InjectionCYHS2500783 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500780 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/02/18Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2500776 Anhui Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 聚乙二醇4000散 · No verified English nameCYHS2500775 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500774 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized; Tianjin Drug Research Institute Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2500767 Beijing Ren Zhong Pharma Co., Ltd. romanized; Anhui Fu Bang Pharma Co., Ltd. romanized
2025/02/18Generic · Class 3 Potassium Phosphates InjectionCYHS2500765 Hua Ren Pharma (Ri Zhao) Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500764 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500763 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500762 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/02/18Generic · Class 3 Relugolix TabletsCYHL2500042 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/02/18New drug · Class 1.1 活血消异颗粒 · No verified English nameCXZL2500013 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized
2025/02/18New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500012 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized
2025/02/18New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500011 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized
2025/02/18New drug · Class 1.1 甲炎康泰颗粒 · No verified English nameCXZL2500010 Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized
2025/02/18New drug · Class 1 BC006单抗注射液 · No verified English nameCXSL2500161 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/02/18New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2500160 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用JSKN003 · No verified English nameCXSL2500159 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500158 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500157 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用SHR-A1904 · No verified English nameCXSL2500156 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2500155 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 1.2 带状疱疹mRNA疫苗 · No verified English nameCXSL2500154 Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Innovation Zhe Biopharmaceuticals Research (Shanghai) Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized
2025/02/18New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500153 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500152 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2500151 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 2.2; 2.4 HR19034滴眼液 · No verified English nameCXHS2500019 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/18New drug · Class 2.2 HXLMT026 · No verified English nameCXHL2500203 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2025/02/18New drug · Class 1 F10胶囊 · No verified English nameCXHL2500202 Chi Feng Fu Na Kang Bio Technology Co., Ltd. romanized; Beijing Fu Na Kang Bio Technology Co., Ltd. romanized
2025/02/18New drug · Class 1 注射用ALK-N001 · No verified English nameCXHL2500201 Zhejiang AngLiKang Pharmaceutical CO.,LTD.

80 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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