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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 442 drug applications between 6 August 2026 and 12 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 78, covering 58 drug names.

2026/08/06 – 2026/08/12

Period
2026/08/06 to 2026/08/12, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
442
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
226

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

442filings, 78 of them generic

By application type

Application typeFilings
Supplement258
Generic78
New drug60
Import32
Unspecified7
Import re-registration7

By drug type

Drug typeFilings
Chemical drug212
TCM157
Therapeutic biologic67
Prophylactic biologic4
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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1替尔泊肽注射液 · No verified English name4122
2Mirogabalin Besilate Tablets3261
3Brexpiprazole Orally Disintegrating Tablets3110
4鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name316
5Upadacitinib Sustained-release Tablets2240
6Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)2217
7Sodium Ibandronate Injection214
8Cyclophosphamide for Injection213
9Tetracaine Hydrochloride Gel215
10盐酸西替利嗪滴剂 · No verified English name217

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

267 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Topfond Pharmaceutical Co., Ltd.870
2Xin Da Bio Technology Co., Ltd. romanized810
3Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized750
4Novo Nordisk A/S710
5Bayer Inc.610
6F. Hoffmann-La Roche Ltd610
7Gilead Sciences Inc.610
8AstraZeneca AB530
9GlaxoSmithKline Trading Services Limited520
10Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized510

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

116 this week

AcceptedDrugApplicants
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600206 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600205 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600204 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600203 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600202 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600201 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600200 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600199 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600198 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600197 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600196 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600195 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600194 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 Verve-102注射液 · No verified English nameJXSL2600193 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/12Import · Class 1 ETX-636 · No verified English nameJXHL2600336 Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited
2026/08/12Import · Class 1 ETX-636 · No verified English nameJXHL2600335 Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited
2026/08/12Generic · Class 3 Tetracaine Hydrochloride GelCYHS2601985 TC Pharmaceuticals (Jiangsu) Co., Ltd
2026/08/12Generic · Class 3 Tetracaine Hydrochloride GelCYHS2601984 TC Pharmaceuticals (Jiangsu) Co., Ltd
2026/08/12Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2601983 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/08/12Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2601982 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/08/12Generic · Class 3 硫酸锌注射液 · No verified English nameCYHS2601980 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2026/08/12Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2601979 Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/08/12Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2601978 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2026/08/12Generic · Class 3 Amoxicillin CapsulesCYHS2601976 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized
2026/08/12Generic · Class 3 Amoxicillin CapsulesCYHS2601975 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized
2026/08/12Generic · Class 3 Tebipenem Pivoxil Fine GranulesCYHL2600087 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/08/12New drug · Class 3.1 真武汤颗粒 · No verified English nameCXZS2600046 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2026/08/12New drug · Class 1.1 十味安肠颗粒 · No verified English nameCXZL2600075 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized; Liaoning Bei Feng Pharma Co., Ltd. romanized
2026/08/12New drug · Class 1 TJ101注射液 · No verified English nameCXSS2600122 Tian Jing Bio Pharma (Hangzhou) Co., Ltd. romanized
2026/08/12New drug · Class 1 SKB118注射液 · No verified English nameCXSL2600856 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized

86 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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