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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 365 drug applications between 16 May 2025 and 22 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 59 drug names.

2025/05/16 – 2025/05/22

Period
2025/05/16 to 2025/05/22, 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
365
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
44

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

365filings, 78 of them generic

By application type

Application typeFilings
Supplement195
Generic78
New drug61
Import17
Unspecified12
Import re-registration2

By drug type

Drug typeFilings
Chemical drug222
TCM76
Therapeutic biologic58
Prophylactic biologic6
Biologic3

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Oral Solution4211
2维立西呱片 · No verified English name318
3Glucosamine Sulfate Capsules2251
4Iguratimod Tablets2223
5丙戊酸钠缓释微片 · No verified English name210
6地氯雷他定口服溶液 · No verified English name2126
7复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
8Vonoprazan Fumarate Tablets2160
9Brivaracetam Tablets2119
10Methylprednisolone Sodium Succinate for injection2112

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

225 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized17160
2AstraZeneca AB840
3Hong Tao Kai Pharma Co., Ltd. romanized660
4Changzhou Pharmaceutical Factory Co., Ltd. romanized525
5Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized520
6CISEN PHARMACEUTICAL CO., LTD.521
7Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized440
8Hainan Hai Li Pharmaceutical Co., Ltd. romanized441
9Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized432
10Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.422

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

111 this week

AcceptedDrugApplicants
2025/05/22Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2500080 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2025/05/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501850 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2025/05/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501849 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2025/05/22Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2501844 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2025/05/22Generic · Class 3 Potassium Chloride Oral SolutionCYHS2501842 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/22Generic · Class 3 Potassium Chloride Oral SolutionCYHS2501841 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/22Generic · Class 3 Potassium Chloride Oral SolutionCYHS2501840 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/22Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500097 Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2025/05/22New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSS2500052 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/05/22New drug · Class 1 GR2001注射液 · No verified English nameCXSS2500051 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/05/22New drug · Class 1 注射用TJ101 · No verified English nameCXSL2500413 Yi Xian Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/05/22New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2500412 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized
2025/05/22New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500411 Hua Lan Bio Yi Miao Co., Ltd. romanized
2025/05/22New drug · Class 1 苯甲酸安达替尼胶囊 · No verified English nameCXHS2500055 An Shi Pharma (Ningbo) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/05/22New drug · Class 1 苯甲酸安达替尼胶囊 · No verified English nameCXHS2500054 An Shi Pharma (Ningbo) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/05/22New drug · Class 1 MDI-1228_mesylate滴鼻液 · No verified English nameCXHL2500502 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/22New drug · Class 1 MDI-1228_mesylate滴鼻液 · No verified English nameCXHL2500501 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/22New drug · Class 1 注射用DYX116 · No verified English nameCXHL2500500 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/05/22New drug · Class 1 注射用DYX116 · No verified English nameCXHL2500499 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/05/22New drug · Class 1 HW241045片 · No verified English nameCXHL2500498 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2025/05/22New drug · Class 1 HW241045片 · No verified English nameCXHL2500497 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2025/05/22New drug · Class 2.3 TAP-1504凝胶 · No verified English nameCXHL2500496 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2025/05/21Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500063 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/21Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500062 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/21Import · Class 1 注射用Felzartamab · No verified English nameJXSL2500079 Biogen Idec Research Limited
2025/05/21Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2501839 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/05/21Generic · Class 3 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2501835 Gan Li Pharma Shandong Co., Ltd. romanized
2025/05/21Generic · Class 3 Bilastine Oral SolutionCYHS2501831 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/05/21Generic · Class 3 Colesevelam Hydrochloride TabletsCYHS2501828 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/05/21Generic · Class 3 丙戊酸钠缓释微片 · No verified English nameCYHL2500095 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized

81 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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