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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 20 November 2025 and 26 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 61 drug names.

2025/11/20 – 2025/11/26

Period
2025/11/20 to 2025/11/26, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
83

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

323filings, 73 of them generic

By application type

Application typeFilings
Supplement151
Generic73
New drug58
Unspecified19
Import13
Import re-registration9

By drug type

Drug typeFilings
Chemical drug168
TCM96
Therapeutic biologic46
Biologic11
Prophylactic biologic2

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets3270
2Paliperidone Palmitate Injection318
3氢溴酸加兰他敏口崩片 · No verified English name313
4Tacrolimus Ointment216
5Folic Acid Tablets2112
6Empagliflozin Tablets2118
7Sildenafil Citrate Tablets2112
8氯雷他定糖浆 · No verified English name217
9Loxoprofen Sodium Patches2130
10中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name117

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized880
2Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized720
3Guangdong Lei Yun Shang Pharma Co., Ltd. romanized550
4Novartis Pharma AG540
5Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized540
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7Topfond Pharmaceutical Co., Ltd.440
8Sichuan Shu Zhong Pharma Co., Ltd. romanized430
9Jiangxi Qing Chun Kang Yuan Pharmaceutical Co., Ltd. romanized420
10Shenyang San Sheng Pharmaceutical 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

85 this week

AcceptedDrugApplicants
2025/11/26Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2500139 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/11/26Generic · Class 3 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504070 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2025/11/26Generic · Class 3 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504069 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2025/11/26Generic · Class 3 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504068 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2025/11/26Generic · Class 3 Flurbiprofen PatchesCYHL2500209 Shaanxi Pan Long Pharma Group Co., Ltd. romanized
2025/11/26New drug · Class 1 IBI3013 · No verified English nameCXSL2501010 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/26New drug · Class 1 IBI3013 · No verified English nameCXSL2501009 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/26New drug · Class 3.4 人凝血因子Ⅸ · No verified English nameCXSL2501008 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2025/11/26New drug · Class 1 注射用HBT-708 · No verified English nameCXSL2501007 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/26New drug · Class 1 注射用HBT-708 · No verified English nameCXSL2501006 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/26New drug · Class 2.4 盐酸恩沙替尼胶囊 · No verified English nameCXHS2500143 Bei Da Pharma Co., Ltd. romanized
2025/11/26New drug · Class 2.4 盐酸恩沙替尼胶囊 · No verified English nameCXHS2500142 Bei Da Pharma Co., Ltd. romanized
2025/11/26New drug · Class 2.2 SBK014干混悬剂 · No verified English nameCXHL2501296 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/26New drug · Class 1 ZB-002片 · No verified English nameCXHL2501295 Guizhou Yi Ke University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized
2025/11/26New drug · Class 1 ZB-002片 · No verified English nameCXHL2501294 Guizhou Yi Ke University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized
2025/11/25Import · Class 1 注射用Abelacimab · No verified English nameJXSL2500227 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/25Import · Class 1 PIT565 · No verified English nameJXSL2500226 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/25Import · Class 1 E6742 · No verified English nameJXHL2500363 Eisai Co. Ltd.; Eisai China Inc.
2025/11/25Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2504063 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2025/11/25Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504056 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/25Generic · Class 3 Colchicine TabletsCYHS2504054 Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
2025/11/25Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504051 Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/11/25New drug · Class 1.1 清瘟止咳颗粒 · No verified English nameCXZL2500119 Jiangxi Bao Zhong Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 2.3 女珍颗粒 · No verified English nameCXZL2500118 Shandong Feng Huang Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 1 注射用ASKG915 · No verified English nameCXSL2501005 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2025/11/25New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2501004 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2501003 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2501002 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 VC005片 · No verified English nameCXHL2501293 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2501292 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized

55 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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