YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 20 September 2025 and 26 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 42 drug names.

2025/09/20 – 2025/09/26

Period
2025/09/20 to 2025/09/26, 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
317
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
60

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

317filings, 55 of them generic

By application type

Application typeFilings
Supplement176
Generic55
New drug55
Import20
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug176
TCM79
Therapeutic biologic57
Biologic2
Prophylactic biologic2
Unspecified1

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

42 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
4Cefditoren Pivoxil Granules2118
5Levocarnitine Oral Solution219
6注射用氨苄西林钠舒巴坦钠/氯化钠注射液 · No verified English name212
7Loxoprofen Sodium Patches2130
8Atomoxetine Hydrochloride Capsules216
9Mometasone Furoate Cream2116
10Polidocanol Injection2123

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ke Lun Pharma Co., Ltd. romanized1520
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized1180
3AstraZeneca AB730
4Otsuka Pharmaceutical Co.,Ltd.610
5Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized510
6Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440
7Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized420
8Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized420
9Hangzhou Minsheng Pharmaceutical Co., Ltd420
10pharmaand GmbH410

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

83 this week

AcceptedDrugApplicants
2025/09/26Import · Class 1 AZD0486 · No verified English nameJXSL2500186 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/26Import · Class 1 AZD0486 · No verified English nameJXSL2500185 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/26Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSL2500184 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/26Import · Class 2.4 Fitusiran注射液 · No verified English nameJXHL2500300 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/09/26Import · Class 2.4 Fitusiran注射液 · No verified English nameJXHL2500299 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/09/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503521 Henan Hua Luo Kang Run Pharma Co., Ltd. romanized
2025/09/26Generic · Class 3 Indobufen TabletsCYHS2503519 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Henan Fu Sen Pharma Co., Ltd. romanized
2025/09/26New drug · Class 1 GB10注射液 · No verified English nameCXSL2500841 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2025/09/26New drug · Class 1 N-3C01注射液 · No verified English nameCXSL2500834 Hefei Xin Zhu Bio Technology Co., Ltd. romanized
2025/09/26New drug · Class 1 BSI-082注射液 · No verified English nameCXSL2500833 Bo Ao Xin Bio Technology (Nanjing) Co., Ltd. romanized
2025/09/26New drug · Class 1 SIM0811注射液 · No verified English nameCXHL2501035 Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Hainan Xian Sheng Pharma Co., Ltd. romanized
2025/09/25Import · Class 1 Budoprutug注射液 · No verified English nameJXSL2500183 Climb Bio Inc.; Beijing Mabworks Biotech Company Limited
2025/09/25Import · Class 2.4 Fitusiran注射液 · No verified English nameJXHL2500298 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/09/25Generic · Class 3 Potassium Chloride Oral SolutionCYHS2503516 Anhui Kang Rong Pharma Co., Ltd. romanized
2025/09/25Generic · Class 3 地塞米松磷酸钠滴眼液 · No verified English nameCYHS2503514 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized
2025/09/25Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2503513 Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/09/25Generic · Class 3 Doxycycline Hyclate TabletsCYHS2503512 Chengdu Shuo De Pharma Co., Ltd. romanized
2025/09/25Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2503509 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2025/09/25Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500174 Ou Pu Kang Shi Technology Co., Ltd. romanized
2025/09/25New drug · Class 1.1 天龙通络颗粒 · No verified English nameCXZL2500086 Beijing Guo Ren Tang Pharmaceuticals Technology Development Co., Ltd. romanized
2025/09/25New drug · Class 1 N-3C01注射液 · No verified English nameCXSL2500832 Hefei Xin Zhu Bio Technology Co., Ltd. romanized
2025/09/25New drug · Class 1 注射用HLX87 · No verified English nameCXSL2500831 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2025/09/25New drug · Class 1 HLX22单抗注射液 · No verified English nameCXSL2500830 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized
2025/09/25New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500829 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/09/25New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSL2500828 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/09/25New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSL2500827 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/09/25New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2500826 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2025/09/25New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2500825 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2025/09/25New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2500824 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2025/09/25New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2500823 Chengdu Hong Ji Bio Technology Co., Ltd. romanized

53 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.