YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 404 drug applications between 30 March 2026 and 5 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.
2026/03/30 – 2026/04/05
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- Accepted this week, now under review
- 100
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
404filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 274 |
| New drug | 53 |
| Generic | 43 |
| Import | 18 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 175 |
| Chemical drug | 166 |
| Therapeutic biologic | 61 |
| Biologic | 1 |
| Prophylactic biologic | 1 |
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
32 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 | Linagliptin and Metformin Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 4 | Carboplatin Injection | 2 | 1 | 10 |
| 5 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 6 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 7 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 8 | Labetalol Hydrochloride Tablets | 2 | 1 | 3 |
| 9 | 褪黑素颗粒 · No verified English name | 2 | 1 | 12 |
| 10 | Acetylcysteine Injection | 1 | 1 | 53 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 14 | 5 | 0 |
| 2 | Hubei Tai Zi Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 10 | 10 | 0 |
| 4 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 8 | 2 | 0 |
| 6 | Jiangsu Ke Lun Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 7 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 8 | Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 4 | 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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/04/04Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2600785 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/04/04New drug · Class 2.3 | 椿乳凝胶 · No verified English nameCXZL2600034 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized |
| 2026/04/04New drug · Class 1 | SK-NK注射液 · No verified English nameCXSL2600380 | Sai Ao Si Bo Bio Technology (Beijing) Co., Ltd. romanized; Sai Ao Si Bo Bio Technology (Zhengzhou) Co., Ltd. romanized |
| 2026/04/03Import · Class 2.2 | 注射用维恩妥尤单抗 · No verified English nameJXSL2600091 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2026/04/03Import · Class 2.2 | 注射用维恩妥尤单抗 · No verified English nameJXSL2600090 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2026/04/03Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2600099 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/04/03Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2600784 | Anhui Yuan Wang Le Huan Pharma Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | GT307注射液 · No verified English nameCXSL2600379 | Beijing Sha Li Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | SAR445877注射用浓溶液 · No verified English nameCXSL2600378 | Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | ATTO-1310注射液 · No verified English nameCXSL2600377 | Ai Tuo Wei Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 9MW5211注射液 · No verified English nameCXSL2600376 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 注射用DXC018 · No verified English nameCXSL2600375 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 注射用SIM0689 · No verified English nameCXSL2600374 | Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 艾普美妥司他片 · No verified English nameCXHS2600047 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 艾普美妥司他片 · No verified English nameCXHS2600046 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | 伊托法替布软膏 · No verified English nameCXHS2600045 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | D-0120-NA片 · No verified English nameCXHL2600406 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/03New drug · Class 1 | VC005凝胶 · No verified English nameCXHL2600405 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/03New drug · Class 2.2 | 优替德隆胶囊 · No verified English nameCXHL2600404 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/02Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600027 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S. p. A.; MSD R&D (China) Co. Ltd |
| 2026/04/02Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600026 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/04/02Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSS2600025 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/04/02Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSS2600024 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2026/04/02Import · Class 1 | PF-08634404 · No verified English nameJXSL2600089 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/04/02Import · Class 1 | AZD8965片 · No verified English nameJXHL2600098 | AstraZeneca AB; Name not romanized |
| 2026/04/02Import · Class 1 | AZD8965片 · No verified English nameJXHL2600097 | AstraZeneca AB; Name not romanized |
49 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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