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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 15 May 2025 and 21 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 68 drug names.

2025/05/15 – 2025/05/21

Period
2025/05/15 to 2025/05/21, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
51

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

392filings, 97 of them generic

By application type

Application typeFilings
Supplement206
Generic97
New drug55
Import19
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug249
TCM80
Therapeutic biologic55
Prophylactic biologic5
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

68 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
2Risperidone Oral Solution416
3Calcium Acetate Oral Solution411
4Aripiprazole Oral Solution414
5Glucosamine Sulfate Capsules3351
6维立西呱片 · No verified English name318
7维生素B12注射液 · No verified English name226
8丙戊酸钠缓释微片 · No verified English name210
9Vonoprazan Fumarate Tablets2160
10Levofloxacin and Sodium Chloride Injection2114

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized17160
2Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
3Hong Tao Kai Pharma Co., Ltd. romanized660
4AstraZeneca AB630
5Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized550
6Changzhou Pharmaceutical Factory Co., Ltd. romanized525
7Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized520
8CISEN PHARMACEUTICAL CO., LTD.521
9Hainan Hai Li Pharmaceutical Co., Ltd. romanized441
10Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized432

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

118 this week

AcceptedDrugApplicants
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
2025/05/21Generic · Class 3 丙戊酸钠缓释微片 · No verified English nameCYHL2500094 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2025/05/21New drug · Class 1.4 24价肺炎球菌结合疫苗 · No verified English nameCXSL2500410 Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 注射用MHB042C · No verified English nameCXSL2500409 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/05/21New drug · Class 1 人牙囊间充质干细胞注射液 · No verified English nameCXSL2500408 Chengdu Shi Lian Kang Jian Bio Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 注射用LB4330 · No verified English nameCXSL2500407 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500405 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/05/21New drug · Class 1 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2500404 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500403 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/05/21New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500402 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/21New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500401 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/05/21New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500400 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/21New drug · Class 2.2 CB345 · No verified English nameCXHL2500495 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 2.2 CB345 · No verified English nameCXHL2500494 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2500493 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2500492 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/21New drug · Class 1 YL-13027片 · No verified English nameCXHL2500491 Shanghai Ying Li Pharma Co., Ltd. romanized
2025/05/21New drug · Class 1 YL-13027片 · No verified English nameCXHL2500490 Shanghai Ying Li Pharma Co., Ltd. romanized
2025/05/20Import · Class 2.2 Tremelimumab注射液 · No verified English nameJXSL2500078 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2500077 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 1 AZD1613注射液 · No verified English nameJXSL2500076 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/05/20Import · Class 2.4 氘可来昔替尼片 · No verified English nameJXHS2500059 Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/05/20Import · Class 1 AZD5305 · No verified English nameJXHL2500119 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.

88 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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