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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 414 drug applications between 22 September 2025 and 28 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 62 drug names.

2025/09/22 – 2025/09/28

Period
2025/09/22 to 2025/09/28, 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
414
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
97

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

414filings, 79 of them generic

By application type

Application typeFilings
Supplement214
Generic79
New drug73
Import26
Import re-registration12
Unspecified10

By drug type

Drug typeFilings
Chemical drug239
TCM98
Therapeutic biologic70
Prophylactic biologic4
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mometasone Furoate Cream4216
2Ezetimibe and Atorvastatin Calcium Tablets(II)229
3Glucosamine Sulfate Capsules2251
4蒙脱石混悬液 · No verified English name2231
5Acetylcysteine Granules214
6Tacrolimus Ointment216
7Carboplatin Injection2110
8Cefditoren Pivoxil Granules2118
9Levocarnitine Oral Solution219
10昂丹司琼口溶膜 · No verified English name212

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

257 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 AB950
4Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized660
5Otsuka Pharmaceutical Co.,Ltd.610
6Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized510
7Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
8Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440
9Pfizer Inc.420
10Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized420

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
2025/09/28Import · Class 3.1 注射用维布妥昔单抗 · No verified English nameJXSS2500129 Takeda Pharma A/S; BSP Pharmaceuticals S.p.A.; Takeda (China) International Trading Co. Ltd
2025/09/28Import · Class 1 Ponsegromab注射液 · No verified English nameJXSL2500189 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/28Import · Class 1 AZD5335 · No verified English nameJXSL2500188 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/28Import · Class 1 AZD0516 · No verified English nameJXSL2500187 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/28Import · Class 1 EVO756片 · No verified English nameJXHL2500302 Maruho Co. Ltd.; Linical (Shanghai) Pharmaceutical Technology Co. Ltd.
2025/09/28Import · Class 1 EVO756片 · No verified English nameJXHL2500301 Maruho Co. Ltd.; Linical (Shanghai) Pharmaceutical Technology Co. Ltd.
2025/09/28Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2503558 Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2025/09/28Generic · Class 3 盐酸沙丙蝶呤散剂 · No verified English nameCYHS2503557 Sichuan De Feng Pharma Co., Ltd. romanized
2025/09/28Generic · Class 3 Gabexate Mesilate For InjectionCYHS2503554 Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2025/09/28Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2503553 Fujian Pin Teng Pharma Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/09/28Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2503552 Fujian Pin Teng Pharma Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/09/28Generic · Class 3 Minoxidil LinimentCYHS2503551 Tang Shan Hong Xing Pharma Co., Ltd. romanized
2025/09/28Generic · Class 3 Minoxidil LinimentCYHS2503550 Tang Shan Hong Xing Pharma Co., Ltd. romanized
2025/09/28Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2503549 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/09/28Generic · Class 3 Cycloserine CapsulesCYHS2503535 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/09/28Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2503533 Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized
2025/09/28Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2503532 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/09/28New drug · Class 1.1 金草止咳口服液 · No verified English nameCXZS2500042 Beijing Lang Zhen Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized
2025/09/28New drug · Class 3.1 异功散颗粒 · No verified English nameCXZS2500041 Shen Wei Pharma Group Co., Ltd. romanized
2025/09/28New drug · Class 1.1 甲炎康泰颗粒 · No verified English nameCXZL2500089 Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized
2025/09/28New drug · Class 1.1 知柏清凉颗粒 · No verified English nameCXZL2500088 Shanghai Shi Biopharmaceuticals Technology Research Institute romanized; Hua Dong Hospital romanized
2025/09/28New drug · Class 1.1 平纳蜜膏 · No verified English nameCXZL2500087 Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized
2025/09/28New drug · Class 1 DB006溶瘤腺病毒注射液 · No verified English nameCXSL2500840 Hainan Ji Min Bo Ao International Hospital Co., Ltd. romanized; Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2025/09/28New drug · Class 1 注射用XNW28012 · No verified English nameCXSL2500839 Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized
2025/09/28New drug · Class 1.3 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500838 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2025/09/28New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2500837 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/09/28New drug · Class 1 JSKN016注射液 · No verified English nameCXSL2500836 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/09/28New drug · Class 1 SSGJ-627注射液(静脉输注) · No verified English nameCXSL2500835 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2025/09/28New drug · Class 1 HRS-6257片 · No verified English nameCXHL2501047 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/28New drug · Class 1 HRS-6257片 · No verified English nameCXHL2501046 Shanghai Heng Rui Pharmaceuticals 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.

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