YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 428 drug applications between 6 June 2025 and 12 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 129, covering 83 drug names.

2025/06/06 – 2025/06/12

Period
2025/06/06 to 2025/06/12, 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
428
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
66

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

428filings, 129 of them generic

By application type

Application typeFilings
Supplement153
Generic129
New drug82
Import46
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug275
Therapeutic biologic82
TCM61
Biologic5
Prophylactic biologic4
In vitro diagnostic reagent1

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

83 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection201953
2Brexpiprazole Tablets4231
3苯磺酸左氨氯地平片 · No verified English name4245
4Carbidopa and Levodopa Sustained-release Tablets322
5中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name221
6Ethyl Iosapentate Capsules2227
7Bilastine Oral Solution228
8Glucosamine Sulfate Capsules2251
9Lactulose Oral Solution2134
10Folic acid injection211

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

281 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Merck Sharp & Dohme B.V.2520
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
3Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized550
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.545
5Qilu Pharmaceutical Co., Ltd.541
6Xian Da Heng Pharmaceutical Co., Ltd. romanized440
7Novartis Pharma AG430
8Jiangsu Hao Sen Pharma Group Co., Ltd. romanized420
9Rui Yang Pharmaceutical Co., Ltd. romanized420
10Eli Lilly Nederland B.V.410

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

165 this week

AcceptedDrugApplicants
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500095 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500094 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500093 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500092 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500091 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500090 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500089 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500088 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500087 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500086 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500085 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500084 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500083 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500082 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500081 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500080 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500079 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500078 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500077 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500076 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500075 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500074 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/12Import · Class 1 BMS-986504片 · No verified English nameJXHL2500139 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/06/12Import · Class 1 Baxdrostat片 · No verified English nameJXHL2500138 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/06/12Import · Class 1 Baxdrostat片 · No verified English nameJXHL2500137 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/06/12Import · Class 1 ARV-471(PF-07850327)片 · No verified English nameJXHL2500136 Pfizer Inc; Pfizer Investment CO. Ltd.
2025/06/12Import · Class 1 PF-07248144片 · No verified English nameJXHL2500135 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/12Import · Class 1 PF-07248144片 · No verified English nameJXHL2500134 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/12Import · Class 1 PF-07248144片 · No verified English nameJXHL2500133 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/12Generic · Class 3 多索茶碱口服溶液 · No verified English nameCYHS2502115 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.

135 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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