YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 372 drug applications between 22 August 2025 and 28 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 65 drug names.

2025/08/22 – 2025/08/28

Period
2025/08/22 to 2025/08/28, 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
372
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
87

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

372filings, 95 of them generic

By application type

Application typeFilings
Supplement183
Generic95
New drug49
Import36
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug263
TCM63
Therapeutic biologic41
Biologic3
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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection410
2瑞维那新吸入溶液 · No verified English name3353
3Apalutamide Tablets3318
4Ambroxol Hydrochloride Injection319
5Memantine Hydrochloride OD Tablets312
6Polidocanol Injection3123
7甘油磷酸钠注射液 · No verified English name227
8Iguratimod Tablets2223
9利伐沙班口崩片 · No verified English name214
10Lidocaine and Tetracaine Cream212

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1930
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1290
3Janssen-Cilag International NV940
4NAPP PHARMACEUTICALS LIMITED910
5CSPC OUYI PHARMACEUTICAL CO., LTD.655
6AstraZeneca AB520
7Changchun Jin Sai Pharma Co., Ltd. romanized520
8Qilu Pharmaceutical Co., Ltd.510
9Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440
10Daiichi Sankyo Europe GmbH420

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

114 this week

AcceptedDrugApplicants
2025/08/28Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2500164 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/08/28Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2500163 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/08/28Import · Class 1 MK-0616 片 · No verified English nameJXHL2500245 Merck Sharp & Dohme LLC; Name not romanized
2025/08/28Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2500244 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/08/28New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500744 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/08/28New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500743 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/08/28New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500906 Qilu Pharmaceutical Co., Ltd.
2025/08/28New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500905 Qilu Pharmaceutical Co., Ltd.
2025/08/28New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500904 Qilu Pharmaceutical Co., Ltd.
2025/08/28New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500903 Qilu Pharmaceutical Co., Ltd.
2025/08/28New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500901 Qilu Pharmaceutical Co., Ltd.
2025/08/28New drug · Class 1 SAL0140片 · No verified English nameCXHL2500898 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/28New drug · Class 1 SAL0140片 · No verified English nameCXHL2500897 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/28New drug · Class 1 SAL0140片 · No verified English nameCXHL2500896 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/28New drug · Class 2.2 BIOS2242口服溶液 · No verified English nameCXHL2500895 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/08/28New drug · Class 2.4; 2.2 KEM2408乳胶 · No verified English nameCXHL2500894 Nei Menggu Ke Li Ya Pharma Co., Ltd. romanized
2025/08/28New drug · Class 2.4; 2.2 KEM2408乳胶 · No verified English nameCXHL2500893 Nei Menggu Ke Li Ya Pharma Co., Ltd. romanized
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

84 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.