YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 6 March 2025 and 12 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 76 drug names.

2025/03/06 – 2025/03/12

Period
2025/03/06 to 2025/03/12, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
13

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

377filings, 105 of them generic

By application type

Application typeFilings
Supplement170
Generic105
New drug48
Import re-registration27
Unspecified16
Import11

By drug type

Drug typeFilings
Chemical drug294
TCM38
Therapeutic biologic38
Prophylactic biologic7

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets5231
2Sacubitril Valsartan Sodium Tablets5270
3地氯雷他定口服溶液 · No verified English name4226
4Levofloxacin and Sodium Chloride Injection3114
5Bisoprolol Fumarate and Amlodipine Besylate Tablets229
6洛索洛芬钠凝胶贴膏 · No verified English name229
7Glucosamine Sulfate Capsules2251
8Acipimox Capsules222
9Multiple Vitamins Injection214
10Levetiracetam Tablets216

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17170
2Bracco Imaging S.P.A.1310
3Fresenius Kabi Deutschland GmbH1220
4Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized11101
5Bayer AG630
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized443
8Hubei Wu Shi Pharma Co., Ltd. romanized434
9Qilu Pharmaceutical Co., Ltd.430
10Sichuan Pu Rui Te Pharma Co., Ltd. romanized421

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

86 this week

AcceptedDrugApplicants
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501026 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501025 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2501019 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501018 Tianjin He Zhi Pharma Group Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501017 Tianjin He Zhi Pharma Group Co., Ltd. romanized
2025/03/12Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2501016 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2501015 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2501014 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2500059 Fu Yuan Pharma Co., Ltd. romanized
2025/03/12New drug · Class 1.1 银苓通脉健脑颗粒 · No verified English nameCXZL2500014 Hainan Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized
2025/03/12New drug · Class 1 注射用AX-023(冻干) · No verified English nameCXSL2500221 Beijing An Xin Huai De Bio Technology Co., Ltd. romanized
2025/03/12New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500220 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized
2025/03/12New drug · Class 1 GFH312 片 · No verified English nameCXHL2500273 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/03/12New drug · Class 1 LT-002-158片 · No verified English nameCXHL2500272 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2025/03/12New drug · Class 1 LT-002-158片 · No verified English nameCXHL2500271 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2025/03/12New drug · Class 1 MWX203注射液 · No verified English nameCXHL2500270 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/03/12New drug · Class 2.2 MDN-001注射液 · No verified English nameCXHL2500269 Suzhou Mai De Nuo Yi Medical Technology Co., Ltd. romanized
2025/03/11Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2500036 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/03/11Generic · Class 3 Multiple Vitamins InjectionCYHS2501006 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/11Generic · Class 3 Multiple Vitamins InjectionCYHS2501005 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/11Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2501002 Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/11Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2500997 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/03/11Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2500996 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/03/11New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2500219 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/03/11New drug · Class 2.2 帕尼单抗注射液 · No verified English nameCXSL2500218 Qilu Pharmaceutical Co., Ltd.
2025/03/11New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500217 Qilu Pharmaceutical Co., Ltd.
2025/03/11New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2500216 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500268 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500267 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500266 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized

56 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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