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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 332 drug applications between 13 January 2023 and 19 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 59 drug names.

2023/01/13 – 2023/01/19

Period
2023/01/13 to 2023/01/19, 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
332
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
1

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

332filings, 79 of them generic

By application type

Application typeFilings
Supplement153
Generic79
New drug61
Import re-registration16
Import13
Unspecified10

By drug type

Drug typeFilings
Chemical drug236
TCM51
Therapeutic biologic41
Prophylactic biologic3
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nifedipine Controlled-release Tablets317
2Diquafosol Sodium Eye Drops225
3复方聚乙二醇电解质散(Ⅲ) · No verified English name221
4Regorafenib Tablets223
5Ganirelix Injection221
6Clindamycin Injection214
7Perindopril and Indapamide Tablets213
8Ornidazole Injection210
9Vonoprazan Fumarate Tablets2160
10Ibuprofen Injection218

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized20190
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD730
3Sichuan Pharmaceutical Formulations Co., Ltd. romanized721
4Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized663
5Qilu Pharmaceutical Co., Ltd.665
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
7Kang Zhi Pharma Co., Ltd. romanized550
8An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized540
9Zhejiang Nord Pharmaceutical Co., Ltd434
10Guo Yao Group Guo Rui Pharma Co., Ltd. romanized422

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

94 this week

AcceptedDrugApplicants
2023/01/19Import · Class 1 VSA001注射液 · No verified English nameJXHL2300011 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/19Import · Class 1 BRM421 滴眼液 · No verified English nameJXHL2300010 BRIM Biotechnology Inc.; Grandpharma (China) Co. Ltd.
2023/01/19Generic · Class 3 Ornidazole InjectionCYHS2300196 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/01/19Generic · Class 3 Ornidazole InjectionCYHS2300195 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/01/19Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2300192 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300190 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300189 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 Peramivir InjectionCYHS2300186 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2023/01/19Generic · Class 3 Nimodipine Oral SolutionCYHS2300185 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300183 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2300182 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/01/19New drug · Class 1.1 杏芩感咳颗粒 · No verified English nameCXZL2300001 Shanghai Zhong Pharmaceuticals University romanized; Shijiazhuang Dong Fang Pharma Co., Ltd. romanized
2023/01/19New drug · Class 1 KD6001注射液 · No verified English nameCXSL2300056 Shanghai Kang Dai Biopharmaceuticals Technology Co., Ltd. romanized
2023/01/19New drug · Class 1 HY004细胞注射液 · No verified English nameCXSL2300055 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2023/01/19New drug · Class 1 HY004细胞注射液 · No verified English nameCXSL2300054 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2023/01/19New drug · Class 1 PB103异体自然杀伤(NK)细胞制剂 · No verified English nameCXSL2300053 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2023/01/19New drug · Class 1 PB103异体自然杀伤(NK)细胞制剂 · No verified English nameCXSL2300052 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2023/01/19New drug · Class 1 PB103异体自然杀伤(NK)细胞制剂 · No verified English nameCXSL2300051 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2023/01/19New drug · Class 1 HSK38008干混悬剂 · No verified English nameCXHL2300098 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/19New drug · Class 1 HSK38008干混悬剂 · No verified English nameCXHL2300097 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/19New drug · Class 1 HSK38008干混悬剂 · No verified English nameCXHL2300096 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2023/01/19New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2300095 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2023/01/18Import · Class 3.1 利妥昔单抗注射液(皮下注射) · No verified English nameJXSS2300012 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/01/18Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300011 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/01/18Import · Class 2.2; 2.4 丙酸氯倍他索纳米混悬滴眼液 · No verified English nameJXHL2300009 Formosa Pharmaceuticals Inc.; Grandpharma (China) Co. Ltd.
2023/01/18New drug · Class 1 QLP2117注射液 · No verified English nameCXSL2300050 Qilu Pharmaceutical Co., Ltd.
2023/01/18New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300049 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/01/18New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300048 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/18New drug · Class 1 注射用FZ-AD004抗体偶联剂 · No verified English nameCXSL2300047 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2023/01/18New drug · Class 1 FCN-338片 · No verified English nameCXHL2300094 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized

64 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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