YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 333 drug applications between 7 May 2025 and 13 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 60 drug names.
2025/05/07 – 2025/05/13
- New acceptances this week
- 333
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 30
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
333filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 87 |
| New drug | 60 |
| Import | 19 |
| Unspecified | 5 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 67 |
| Therapeutic biologic | 57 |
| Prophylactic biologic | 4 |
| 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 6 | 3 | 52 |
| 2 | Penicillin G Sodium For Injection | 6 | 1 | 2 |
| 3 | Riociguat Tablets | 3 | 1 | 4 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | 氯雷他定糖浆 · No verified English name | 2 | 2 | 7 |
| 6 | 黄体酮注射液(Ⅱ) · No verified English name | 2 | 2 | 2 |
| 7 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 8 | Carboplatin Injection | 2 | 1 | 10 |
| 9 | Orlistat Capsules | 2 | 1 | 8 |
| 10 | Baricitinib Tablets | 2 | 1 | 32 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | AstraZeneca AB | 9 | 6 | 0 |
| 4 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 8 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 9 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 0 |
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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500060 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500059 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500058 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500057 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500056 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500055 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/13Import · Class 2.4 | Capivasertib片 · No verified English nameJXHL2500109 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2025/05/13Import · Class 2.4 | Capivasertib片 · No verified English nameJXHL2500108 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2025/05/13Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2501720 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/13Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2501717 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/05/13Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2501716 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/05/13Generic · Class 3 | Brivaracetam Oral SolutionCYHL2500091 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/05/13New drug · Class 1 | 注射用重组巴曲酶 · No verified English nameCXSS2500050 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2025/05/13New drug · Class 1 | SYS6026注射液 · No verified English nameCXSL2500376 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/05/13New drug · Class 2.4 | 舒沃替尼片 · No verified English nameCXHL2500462 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/05/13New drug · Class 2.4 | 舒沃替尼片 · No verified English nameCXHL2500461 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/05/12Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSS2500054 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd. |
| 2025/05/12Import · Class 1 | AZD9833片 · No verified English nameJXHL2500107 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2025/05/12Generic · Class 3 | Minoxidil LinimentCYHS2501714 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/05/12Generic · Class 3 | Minoxidil LinimentCYHS2501713 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/05/12Generic · Class 3 | Minoxidil LinimentCYHS2501712 | Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2025/05/12Generic · Class 3 | Minoxidil LinimentCYHS2501711 | Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | EXG202注射液 · No verified English nameCXSL2500375 | Hangzhou Jia Yin Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2500374 | Shanghai Jun Sai Bio Pharma Co., Ltd. romanized; Shanghai Jun Sai Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500050 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500049 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500048 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500047 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/12New drug · Class 1 | 盐酸吉卡昔替尼片 · No verified English nameCXHS2500046 | Name not romanized |
| 2025/05/12New drug · Class 1 | SP-101注射液 · No verified English nameCXHL2500460 | Si Lai Pu Tai (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
82 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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