YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 18 September 2025 and 24 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 53 drug names.

2025/09/18 – 2025/09/24

Period
2025/09/18 to 2025/09/24, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
79

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

290filings, 67 of them generic

By application type

Application typeFilings
Supplement152
Generic67
New drug48
Import11
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug170
TCM69
Therapeutic biologic43
Prophylactic biologic5
Biologic2
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2注射用泼尼松龙琥珀酸钠 · No verified English name313
3Glucosamine Sulfate Capsules2251
4Montelukast Sodium Chewable Tablets214
5Levocarnitine Oral Solution219
6Brexpiprazole Orally Disintegrating Tablets2110
7Brexpiprazole Tablets2131
8Loxoprofen Sodium Patches2130
9Safinamide Methansulfonate Tablets2120
10Mometasone Furoate Cream2116

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ke Lun Pharma Co., Ltd. romanized1520
2Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized770
3AstraZeneca AB630
4Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized520
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized430
6Hangzhou Minsheng Pharmaceutical Co., Ltd420
7Rui Shi Biopharmaceuticals Co., Ltd. romanized410
8Lichtenheldt GmbH330
9Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized330
10Hainan Si Da Pharmaceutical Co., Ltd. romanized331

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

76 this week

AcceptedDrugApplicants
2025/09/24Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2500297 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2025/09/24Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2500296 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2025/09/24New drug · Class 2.2 颅痛宁丸(浓缩丸) · No verified English nameCXZL2500085 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2025/09/24New drug · Class 3.2 布瑞基奥仑赛注射液 · No verified English nameCXSS2500101 Fu Xing Kai Rui (Shanghai) Bio Technology Co., Ltd. romanized
2025/09/24New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2500100 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized
2025/09/24New drug · Class 3.3 BR206注射液 · No verified English nameCXSL2500818 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2025/09/24New drug · Class 1 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2500817 Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized
2025/09/24New drug · Class 1 IMM092注射液 · No verified English nameCXSL2500816 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2025/09/24New drug · Class 1 IMM040811注射液 · No verified English nameCXSL2500815 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2025/09/24New drug · Class 1 177Lu-LNC1009注射液 · No verified English nameCXHL2501029 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2025/09/24New drug · Class 1 Exd391209注射液 · No verified English nameCXHL2501028 Chengdu Ao Da Bio Technology Co., Ltd. romanized
2025/09/24New drug · Class 2.2 DM0205透皮贴剂 · No verified English nameCXHL2501027 Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized
2025/09/24New drug · Class 2.2; 2.4 纳米炭铁混悬注射液 · No verified English nameCXHL2501026 Sichuan Ying Rui Pharmaceuticals Technology Co., Ltd. romanized
2025/09/24New drug · Class 1 RSS0343片 · No verified English nameCXHL2501025 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/24New drug · Class 1 RSS0343片 · No verified English nameCXHL2501024 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/23Import · Class 2.2 艾可瑞妥单抗注射液 · No verified English nameJXSS2500128 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/09/23Import · Class 2.2 艾可瑞妥单抗注射液 · No verified English nameJXSS2500127 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/09/23Generic · Class 3 布美他尼片 · No verified English nameCYHS2503490 Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/09/23Generic · Class 3 Lidocaine Hydrochloride GelCYHS2503489 Sichuan Sheng Yu Xin Pharma Co., Ltd. romanized; Tong Fang Pharma (Beijing) Co., Ltd. romanized
2025/09/23New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSS2500099 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500814 You Sai Sheng Ming Ke Xue Development Co., Ltd. romanized
2025/09/23New drug · Class 1 注射用ATG-022 ADC · No verified English nameCXSL2500813 De Qi (Hangzhou) Bio Co., Ltd. romanized
2025/09/23New drug · Class 1 SHR7280片 · No verified English nameCXHS2500118 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 RSS0343片 · No verified English nameCXHL2501023 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 RSS0343片 · No verified English nameCXHL2501022 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 XRF-1021片 · No verified English nameCXHL2501021 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/09/23New drug · Class 1 XRF-1021片 · No verified English nameCXHL2501020 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/09/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2500108 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2500107 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 1 LY3537021注射液 · No verified English nameJXHL2500295 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd

46 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.