YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 22 September 2026 and 28 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 37 drug names.

2026/09/22 – 2026/09/28

Period
2026/09/22 to 2026/09/28, 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
345
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
278

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

345filings, 47 of them generic

By application type

Application typeFilings
Supplement183
New drug54
Generic47
Import34
Import re-registration16
Unspecified11

By drug type

Drug typeFilings
Chemical drug185
TCM91
Therapeutic biologic62
Biologic5
Prophylactic biologic2

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

37 drugs with new generic filings; top 10 listed

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH910
2Pfizer Inc.910
3Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
4Shaanxi Ou Ke Pharma Co., Ltd. romanized660
5Xian Wan Long Pharmaceutical Co., Ltd. romanized550
6Jiangxi Pin Xin Pharma Co., Ltd. romanized520
7Boehringer Ingelheim International GmbH510
8Shanxi Wang Long Pharma Group Co., Ltd. romanized440
9Yuan Da Bei Lin (Xian) Pharma Co., Ltd. romanized440
10Te Yi Pharma Group 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

102 this week

AcceptedDrugApplicants
2026/09/28Import · Class 1 AMG 732 · No verified English nameJXSL2600261 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600428 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600427 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600426 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600425 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600424 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600423 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600422 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600421 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600420 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600419 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060 · No verified English nameJXHL2600418 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Generic · Class 3 溴吡斯的明口服溶液 · No verified English nameCYHS2602419 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2026/09/28Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2602416 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2026/09/28Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2602415 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized
2026/09/28New drug · Class 1.1 消肿颗粒 · No verified English nameCXZL2600095 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2026/09/28New drug · Class 2.4 注射用重组A型肉毒毒素(150 kD) · No verified English nameCXSS2600156 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2026/09/28New drug · Class 1 注射用AP308 · No verified English nameCXSL2601066 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 9MW2821 · No verified English nameCXSL2601065 Mai Wei (Shang Tao) Bio Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 YYSW001片 · No verified English nameCXHL2601211 Yi You Bio (Shanghai) Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Meng Yang Pharma (Shanghai) Co., Ltd. romanized
2026/09/28New drug · Class 1 注射用TNP-2092 · No verified English nameCXHL2601210 Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2026/09/28New drug · Class 1 BG-92505片 · No verified English nameCXHL2601209 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 BG-92505片 · No verified English nameCXHL2601208 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 注射用莱古比星 · No verified English nameCXHL2601207 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 YKYY018雾化吸入剂 · No verified English nameCXHL2601206 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2026/09/28New drug · Class 1 YKYY018雾化吸入剂 · No verified English nameCXHL2601205 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2026/09/24Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2600260 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/09/24Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2600123 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2600122 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 赛沃替尼片 · No verified English nameJXHL2600417 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

72 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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