YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 22 November 2025 and 28 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 64 drug names.
2025/11/22 – 2025/11/28
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 89
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
338filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 77 |
| New drug | 51 |
| Import | 25 |
| Unspecified | 15 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 190 |
| TCM | 92 |
| Therapeutic biologic | 49 |
| Biologic | 5 |
| Prophylactic biologic | 2 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 3 | 2 | 22 |
| 2 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 3 | 氢溴酸加兰他敏口崩片 · No verified English name | 3 | 1 | 3 |
| 4 | Tacrolimus Ointment | 2 | 1 | 6 |
| 5 | Folic Acid Tablets | 2 | 1 | 12 |
| 6 | Levonorgestrel Tablets | 2 | 1 | 5 |
| 7 | Empagliflozin Tablets | 2 | 1 | 18 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | 磷苯妥英钠注射用浓溶液 · No verified English name | 2 | 1 | 6 |
| 10 | Roxadustat Capsules | 2 | 1 | 17 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 2 | 0 |
| 2 | Topfond Pharmaceutical Co., Ltd. | 6 | 5 | 2 |
| 3 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Novo Nordisk A/S | 6 | 1 | 0 |
| 5 | Guangdong Lei Yun Shang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Xian Le Xi Medical Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 3 |
| 10 | Beijing Foyou Pharma CO.,LTD | 4 | 3 | 3 |
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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/28Import · Class 1 | 注射用AZD1163 · No verified English nameJXSL2500231 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/11/28Import · Class 1 | 注射用MK-1022 · No verified English nameJXSL2500230 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/11/28Import · Class 1 | AMG 410 · No verified English nameJXHL2500370 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/11/28Import · Class 1 | AMG 410 · No verified English nameJXHL2500369 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/11/28Import · Class 1 | AMG 410 · No verified English nameJXHL2500368 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/11/28New drug · Class 1.1 | 金忆颗粒 · No verified English nameCXZL2500122 | Hangzhou Jin Si Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/28New drug · Class 1 | HL08 · No verified English nameCXSL2501018 | Hua Lan Bio Gong Cheng Co., Ltd. romanized |
| 2025/11/28New drug · Class 1 | HL08 · No verified English nameCXSL2501017 | Hua Lan Bio Gong Cheng Co., Ltd. romanized |
| 2025/11/28New drug · Class 1 | HS-10390片 · No verified English nameCXHL2501305 | Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500145 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500144 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500143 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500142 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500141 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 2.2 | 帕西生长激素注射液 · No verified English nameJXSS2500140 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2025/11/27Import · Class 1 | Lesigercept注射液 · No verified English nameJXSL2500229 | Yuhan Corporation; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/11/27Import · Class 1 | HMBD-001 · No verified English nameJXSL2500228 | Hummingbird Bioscience Pte Ltd; Harvest Integrated Research Organization |
| 2025/11/27Import · Class 1 | MK-1084片 · No verified English nameJXHL2500365 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/11/27Import · Class 1 | MK-1084片 · No verified English nameJXHL2500364 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/11/27Generic · Class 3 | Cyclophosphamide CapsulesCYHS2504092 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504091 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504090 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | 阿法骨化醇口服溶液 · No verified English nameCYHS2504089 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | Sodium Lactate Ringer's Irrigation SolutionCYHS2504088 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2504084 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/11/27Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2504083 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/11/27New drug · Class 1.2 | 美蠊复新液 · No verified English nameCXZL2500121 | Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized |
| 2025/11/27New drug · Class 1.2 | 美蠊复新液 · No verified English nameCXZL2500120 | Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized |
| 2025/11/27New drug · Class 3.4 | 痘苗病毒致炎兔皮提取物片 · No verified English nameCXSS2500126 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2025/11/27New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2501016 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
65 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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