YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 365 drug applications between 26 November 2025 and 2 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 61 drug names.

2025/11/26 – 2025/12/02

Period
2025/11/26 to 2025/12/02, 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)
61
Accepted this week, now under review
92

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
Supplement187
Generic78
New drug62
Import22
Unspecified14
Import re-registration2

By drug type

Drug typeFilings
Chemical drug216
TCM90
Therapeutic biologic53
Biologic5
Prophylactic 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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection318
2氢溴酸加兰他敏口崩片 · No verified English name313
3Pemafibrate Tablets2223
4Crisaborole Ointment2226
5Tacrolimus Ointment216
6复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
7Levonorgestrel Tablets215
8Empagliflozin Tablets2118
9Teneligliptin Hydrobromide Hydrate Tablets2110
10Levocetirizine dihydrochloride Oral Solution215

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized990
2Novo Nordisk A/S920
3Hunan Ke Lun Pharmaceutical Co., Ltd. romanized721
4Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized620
5Xian Le Xi Medical Technology Co., Ltd. romanized550
6Beijing Sai Er Bio Pharma Co., Ltd. romanized545
7Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized510
8Guangzhou Bai Yun Shan Hua Cheng Pharma Co., Ltd. romanized440
9Merck Sharp & Dohme LLC430
10Topfond Pharmaceutical Co., Ltd.432

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

106 this week

AcceptedDrugApplicants
2025/12/02Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504138 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/12/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504126 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504125 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/02Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2504121 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2025/12/02Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2500211 Tianjin Hong Ri Pharma Co., Ltd. romanized
2025/12/02New drug · Class 1.1 疏肝解郁颗粒 · No verified English nameCXZS2500048 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Kang Mei Bao Ning (Sichuan) Pharmaceutical Co., Ltd. romanized
2025/12/02New drug · Class 1.1 黑黄赤珠颗粒 · No verified English nameCXZL2500124 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/12/02New drug · Class 2.3 血府逐瘀口服液 · No verified English nameCXZL2500123 Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized
2025/12/02New drug · Class 1 BPAb002注射液 · No verified English nameCXSL2501032 Bo Pin Ze Rong (Shenzhen) Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/02New drug · Class 1 VERT-002注射液 · No verified English nameCXSL2501031 Pi Er Fa Bo (Shanghai) Medical Technology Co., Ltd. romanized
2025/12/02New drug · Class 1 HT-102注射液 · No verified English nameCXSL2501030 Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized; An Ji Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized
2025/12/02New drug · Class 1 注射用GQ1001冻干粉针剂 · No verified English nameCXSL2501029 Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2025/12/02New drug · Class 2.4 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2500146 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/02New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2501317 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/02New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2501316 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/02New drug · Class 1 HT-101注射液 · No verified English nameCXHL2501315 Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized; An Ji Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized
2025/12/01Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2504127 Shandong Qidu Pharmaceutical Co., Ltd.
2025/12/01Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHL2500210 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/29Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500147 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500146 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 1 JNJ-88545223片 · No verified English nameJXHL2500367 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Import · Class 1 JNJ-88545223片 · No verified English nameJXHL2500366 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Generic · Class 3 Acetylcysteine TabletsCYHS2504115 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/11/29Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2504113 Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2504112 Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 Bromhexine Hydrochloride TabletsCYHS2504110 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2504109 Chongqing Ren Ze Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/11/29Generic · Class 3 ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2504108 Zhejiang Guo Jing Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2025/11/29New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2501028 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/11/29New drug · Class 1 注射用SSS57 · No verified English nameCXSL2501027 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized

76 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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