YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 340 drug applications between 21 August 2025 and 27 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 66 drug names.

2025/08/21 – 2025/08/27

Period
2025/08/21 to 2025/08/27, 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
340
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
88

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

340filings, 93 of them generic

By application type

Application typeFilings
Supplement166
Generic93
New drug37
Import34
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug242
TCM51
Therapeutic biologic43
Biologic2
Unspecified1
Prophylactic 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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection410
2Fexofenadine Hydrochloride Tablets4110
3Apalutamide Tablets3318
4Ambroxol Hydrochloride Injection319
5Memantine Hydrochloride OD Tablets312
6Polidocanol Injection3123
7利伐沙班口崩片 · No verified English name214
8Lidocaine and Tetracaine Cream212
9注射用哌拉西林钠/氯化钠注射液 · No verified English name212
10注射用头孢唑肟钠 · No verified English name214

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

201 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company2230
2NAPP PHARMACEUTICALS LIMITED910
3Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized850
4Changchun Jin Sai Pharma Co., Ltd. romanized741
5AstraZeneca AB720
6CSPC OUYI PHARMACEUTICAL CO., LTD.655
7Janssen-Cilag International NV630
8Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440
9Daiichi Sankyo Europe GmbH420
10Ha Yao Group Pharmaceutical Factory romanized410

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

105 this week

AcceptedDrugApplicants
2025/08/27Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2500162 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/08/27Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2500161 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/08/27Import · Class 1 AZD0486 · No verified English nameJXSL2500160 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/27Import · Class 1 AZD0486 · No verified English nameJXSL2500159 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500243 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500242 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500241 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500240 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500239 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Import · Class 1 Orforglipron片 · No verified English nameJXHL2500238 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/27Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2503147 CISEN PHARMACEUTICAL CO., LTD.
2025/08/27Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2503146 CISEN PHARMACEUTICAL CO., LTD.
2025/08/27Generic · Class 3 盐酸利多卡因胶浆 · No verified English nameCYHS2503138 Guangdong Jun Kang Pharma Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/08/27New drug · Class 1 QT-019B细胞注射液 · No verified English nameCXSL2500745 Hangzhou Qi Han Bio Technology Co., Ltd. romanized
2025/08/27New drug · Class 1 G01滴眼液 · No verified English nameCXSL2500742 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2025/08/27New drug · Class 1 G01滴眼液 · No verified English nameCXSL2500741 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2025/08/27New drug · Class 1 G01滴眼液 · No verified English nameCXSL2500740 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2025/08/27New drug · Class 1 G01滴眼液 · No verified English nameCXSL2500739 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2025/08/27New drug · Class 1 GenSci134注射液 · No verified English nameCXSL2500738 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/08/27New drug · Class 1 GenSci134注射液 · No verified English nameCXSL2500737 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/08/27New drug · Class 1 WSK-V108E · No verified English nameCXSL2500736 Beijing Wei Si Ke Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized
2025/08/27New drug · Class 1 WGc-0201 注射液 · No verified English nameCXSL2500735 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/27New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHL2500892 Beijing Shang Xiu Tang Pharmaceuticals Technology Co., Ltd. romanized
2025/08/27New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHL2500891 Beijing Shang Xiu Tang Pharmaceuticals Technology Co., Ltd. romanized
2025/08/27New drug · Class 2.4 瑞维鲁胺片 · No verified English nameCXHL2500890 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/26Import · Class 1 AZD0486 · No verified English nameJXSL2500158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/26Import · Class 1 AZD0486 · No verified English nameJXSL2500157 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/26Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503131 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503130 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2503129 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized

75 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.