YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 2 April 2026 and 8 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 31 drug names.
2026/04/02 – 2026/04/08
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- Accepted this week, now under review
- 78
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
304filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 40 |
| New drug | 37 |
| Import | 16 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 132 |
| Chemical drug | 126 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 3 |
| 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | Arginine and Ibuprofen Granules | 3 | 1 | 11 |
| 3 | Carboplatin Injection | 2 | 1 | 10 |
| 4 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 5 | Erythromycin Lactobionate for Injection | 2 | 1 | 13 |
| 6 | Dexmethylphenidate Hydrochloride Exended-release Capsules | 2 | 1 | 2 |
| 7 | 褪黑素颗粒 · No verified English name | 2 | 1 | 12 |
| 8 | Acetylcysteine Injection | 1 | 1 | 53 |
| 9 | Edaravone and Dexborneol Concentrated Solution for Injection | 1 | 1 | 34 |
| 10 | Celecoxib Capsules | 1 | 1 | 5 |
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
168 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Tai Zi Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 12 | 5 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 10 | 10 | 0 |
| 4 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 8 | 2 | 0 |
| 6 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 3 | 0 |
| 8 | Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Er Factory romanized | 4 | 4 | 0 |
| 9 | Name not romanized | 4 | 3 | 0 |
| 10 | Shandong Feng Huang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
61 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/08Generic · Class 3 | Potassium Chloride GranulesCYHS2600797 | Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized |
| 2026/04/08Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2600795 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/04/08Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2600794 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/04/08Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2600793 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2026/04/08Generic · Class 3 | Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600792 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/08Generic · Class 3 | Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600791 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/08New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2600383 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | HCL001 细胞注射液 · No verified English nameCXSL2600382 | Shanghai Hui Cun Medical Technology Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | 泽普昔替尼胶囊 · No verified English nameCXHS2600049 | Ling Ke Pharma (Zhejiang) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/04/08New drug · Class 2.2; 2.4 | 富马酸伏诺拉生氯化钠注射液 · No verified English nameCXHS2600048 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | PC-0120片 · No verified English nameCXHL2600420 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | HSK46256片 · No verified English nameCXHL2600419 | Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | HSK46256片 · No verified English nameCXHL2600418 | Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600417 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600416 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600415 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600412 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600411 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/08New drug · Class 1 | VVD-133214 片 · No verified English nameCXHL2600410 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/04/07Generic · Class 3 | 盐酸他喷他多口服溶液 · No verified English nameCYHL2600038 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | SYS6041 · No verified English nameCXSL2600381 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | ANS02胶囊 · No verified English nameCXHL2600414 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | ANS02胶囊 · No verified English nameCXHL2600413 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | 68Ga-NYM096注射液制备用药盒 · No verified English nameCXHL2600409 | Anhui Nuo Yu Biopharmaceutical Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | LT-010391片 · No verified English nameCXHL2600408 | Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized |
| 2026/04/07New drug · Class 1 | LT-010391片 · No verified English nameCXHL2600407 | Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized |
| 2026/04/04Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600031 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/04/04Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600030 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/04/04Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600029 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/04/04Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600028 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
31 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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