YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 3 April 2026 and 9 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 41 drug names.

2026/04/03 – 2026/04/09

Period
2026/04/03 to 2026/04/09, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
98

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

368filings, 56 of them generic

By application type

Application typeFilings
Supplement233
Generic56
New drug46
Import22
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug170
TCM146
Therapeutic biologic46
Biologic3
Prophylactic 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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension3214
2Tadalafil Tablets3123
3Topiramate Extended-release Capsules310
4Carboplatin Injection2110
5Diclofenac Diethylamine Emulgel2120
6Vonoprazan Fumarate Tablets2160
7Erythromycin Lactobionate for Injection2113
8Dexmethylphenidate Hydrochloride Exended-release Capsules212
9Ambroxol Hydrochloride Oral Solution2146
10Memantine Hydrochloride Sustained-release Capsules212

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1570
2Hebei Wan Sui Pharma Co., Ltd. romanized13120
3Hubei Tai Zi Pharma Co., Ltd. romanized12120
4Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized980
5Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized880
6Merck Sharp & Dohme B.V.610
7Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized610
8Boehringer Ingelheim International GmbH510
9Shandong Feng Huang Pharmaceutical Co., Ltd. romanized430
10Bristol-Myers Squibb Pharma EEIG420

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

83 this week

AcceptedDrugApplicants
2026/04/09Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600033 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/04/09Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600032 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600109 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600108 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600107 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600105 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 GSK6042981片 · No verified English nameJXHL2600104 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/04/09Import · Class 1 PF-07799933片 · No verified English nameJXHL2600103 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2026/04/09Import · Class 2.4 盐酸阿曲生坦片 · No verified English nameJXHL2600102 Novartis Pharma AG
2026/04/09Import · Class 1 PF-07799933片 · No verified English nameJXHL2600101 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2026/04/09Generic · Class 3 厄贝沙坦氨氯地平片(III) · No verified English nameCYHS2600814 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2026/04/09Generic · Class 3 厄贝沙坦氨氯地平片(I) · No verified English nameCYHS2600813 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2026/04/09Generic · Class 3 低钙腹膜透析液(乳酸盐-G2.55%) · No verified English nameCYHS2600812 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/04/09Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2600809 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2026/04/09Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2600808 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2026/04/09Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2600806 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized
2026/04/09Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600042 Hangzhou Bei Te Biopharmaceuticals Co., Ltd. romanized
2026/04/09Generic · Class 3 Topiramate Extended-release CapsulesCYHL2600041 Kun Yao Group Co., Ltd. romanized
2026/04/09Generic · Class 3 Topiramate Extended-release CapsulesCYHL2600040 Kun Yao Group Co., Ltd. romanized
2026/04/09Generic · Class 3 Topiramate Extended-release CapsulesCYHL2600039 Kun Yao Group Co., Ltd. romanized
2026/04/09New drug · Class 3.1 半夏泻心颗粒 · No verified English nameCXZS2600019 Changsha Xin Lin Pharmaceutical Co., Ltd. romanized
2026/04/09New drug · Class 1 注射用帕康曲妥珠单抗 · No verified English nameCXSS2600063 Ying En Bio Technology (Shanghai) Co., Ltd. romanized; Name not romanized
2026/04/09New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600387 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/09New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600386 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/09New drug · Class 1 FB1003重组人源化单克隆抗体注射液 · No verified English nameCXSL2600385 Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/04/09New drug · Class 1 FB1003重组人源化单克隆抗体注射液 · No verified English nameCXSL2600384 Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/04/09New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2600053 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2026/04/09New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2600052 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2026/04/09New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2600051 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized

53 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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