YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 438 drug applications between 1 December 2025 and 7 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 77 drug names.

2025/12/01 – 2025/12/07

Period
2025/12/01 to 2025/12/07, 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
438
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
125

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

438filings, 101 of them generic

By application type

Application typeFilings
Supplement216
Generic101
New drug71
Import25
Import re-registration13
Unspecified12

By drug type

Drug typeFilings
Chemical drug252
TCM118
Therapeutic biologic53
Biologic9
In vitro diagnostic reagent4
Prophylactic 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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Norepinephrine Bitartrate Injection429
2Riociguat Tablets314
3Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
4Mupirocin Ointment2230
5Tadalafil Tablets2123
6多种微量元素注射液(IV) · No verified English name214
7奥洛他定莫米松鼻喷雾剂 · No verified English name211
8恩曲替尼胶囊 · No verified English name216
9Lafutidine Tablets212
10Teneligliptin Hydrobromide Hydrate Tablets2110

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

251 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized30300
2Eli Lilly and Company1210
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
4Ai Min Pharma Group Co., Ltd. romanized550
5Beijing Sai Er Bio Pharma Co., Ltd. romanized545
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
7Terumo Corporation Kofu Factory510
8Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized510
9Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized510
10Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized440

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

129 this week

AcceptedDrugApplicants
2025/12/06Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504210 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/12/06Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2504209 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2025/12/06Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2504207 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2025/12/06Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504204 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504203 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 依巴斯汀口崩片 · No verified English nameCYHS2504202 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/12/06Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2504199 Shenzhen Da Fu Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504197 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504196 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504195 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06New drug · Class 3.1 清金化痰颗粒 · No verified English nameCXZS2500049 Shandong Feng Huang Pharmaceutical Co., Ltd. romanized
2025/12/06New drug · Class 1.1 九味儿感颗粒 · No verified English nameCXZL2500125 Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized; Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2025/12/06New drug · Class 2 乙型肝炎病毒表面抗原诊断试剂盒(化学发光法) · No verified English nameCXSS2500135 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 3.3 冻干人用狂犬病疫苗(2BS细胞) · No verified English nameCXSS2500134 Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/12/06New drug · Class 2 人类免疫缺陷病毒抗原抗体诊断试剂盒(化学发光法) · No verified English nameCXSS2500133 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 2 梅毒螺旋体抗体诊断试剂盒(化学发光法) · No verified English nameCXSS2500132 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 2 丙型肝炎病毒抗体诊断试剂盒(化学发光法) · No verified English nameCXSS2500131 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 1 偌考奇拜单抗注射液 · No verified English nameCXSS2500130 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 1 偌考奇拜单抗注射液 · No verified English nameCXSS2500129 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 3.3 IBI3035 · No verified English nameCXSL2501051 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/06New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500152 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/06New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500151 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/06New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500150 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/06New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500149 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/06New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500148 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/06New drug · Class 2.2 PTP23001透皮贴剂 · No verified English nameCXHL2501342 Chongqing Xi Er An Pharma Co., Ltd. romanized
2025/12/06New drug · Class 2.2 PTP23001透皮贴剂 · No verified English nameCXHL2501341 Chongqing Xi Er An Pharma Co., Ltd. romanized
2025/12/06New drug · Class 1 注射用替曲朵辛 · No verified English nameCXHL2501340 Xiamen Zhao Yang Bio Gong Cheng Co., Ltd. romanized
2025/12/05Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2504187 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2025/12/05Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2504186 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized

99 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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