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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 26 February 2025 and 4 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 61 drug names.

2025/02/26 – 2025/03/04

Period
2025/02/26 to 2025/03/04, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
9

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

342filings, 76 of them generic

By application type

Application typeFilings
Supplement196
Generic76
New drug50
Import8
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug215
TCM80
Therapeutic biologic39
Prophylactic biologic7
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
1Oxaliplatin Injection314
2Acetylcysteine Granules214
3Lactulose Oral Solution2134
4Ibrutinib Tablets210
5Procaterol Hydrochloride Solution for Inhalation212
6Famotidine Injection218
7Cefuroxime Sodium for Injection218
8Lysine Acetylsalicylate For Injection218
9盐酸丙卡特罗吸入溶液 · No verified English name213
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized24220
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1430
3Guizhou San Ren Tang Pharma Co., Ltd. romanized880
4Bayer AG810
5Shanghai Min Wei Bio Technology Co., Ltd. romanized810
6Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized660
7Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
8Heilongjiang Han Hong Pharma Co., Ltd. romanized440
9Merck Sharp & Dohme B.V.420
10Zhejiang Wo Wu Bio Technology Co., Ltd. romanized420

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

99 this week

AcceptedDrugApplicants
2025/03/04Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSS2500021 Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd.
2025/03/04Import · Class 1 PIT565 · No verified English nameJXSL2500029 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/04Generic · Class 3 Famotidine InjectionCYHS2500914 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2025/03/04Generic · Class 3 Famotidine InjectionCYHS2500913 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2025/03/04Generic · Class 3 Doxycycline Hyclate TabletsCYHS2500910 TC Pharmaceuticals (Jiangsu) Co., Ltd
2025/03/04Generic · Class 3 Aceclofenac TabletsCYHS2500909 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/03/04Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2500908 Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/03/04Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500905 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2025/03/04Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500904 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2025/03/04Generic · Class 3 Sodium Nitroprusside InjectionCYHS2500903 Kang Pu Pharma Co., Ltd. romanized
2025/03/04New drug · Class 1 注射用BGB-B455 · No verified English nameCXSL2500198 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/03/04New drug · Class 1 NTB003注射液 · No verified English nameCXSL2500197 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/03/04New drug · Class 1 REGEND003细胞自体回输制剂 · No verified English nameCXSL2500196 Shanghai Ji Rui Yi Xue Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 皮炎诊断贴剂02贴 · No verified English nameCXSL2500195 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 皮炎诊断贴剂02贴 · No verified English nameCXSL2500194 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 皮炎诊断贴剂02贴 · No verified English nameCXSL2500193 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 FB1002重组人源化单克隆抗体注射液 · No verified English nameCXSL2500192 Fu Bei Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized
2025/03/04New drug · Class 1 注射用FP008 · No verified English nameCXSL2500191 Zhuhai Fei Peng Pharmaceutical Co., Ltd. romanized
2025/03/04New drug · Class 1.1 6价B族链球菌结合疫苗 · No verified English nameCXSL2500190 Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500242 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500241 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500240 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500239 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 SGB-3383注射液 · No verified English nameCXHL2500238 Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500237 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500236 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500235 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/04New drug · Class 1 MWN109片 · No verified English nameCXHL2500234 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/03Generic · Class 3 醋酸地非法林注射液 · No verified English nameCYHS2500902 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/03/03Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2500901 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized

69 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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