YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 387 drug applications between 14 May 2025 and 20 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 73 drug names.
2025/05/14 – 2025/05/20
- New acceptances this week
- 387
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 59
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
387filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 199 |
| Generic | 104 |
| New drug | 55 |
| Import | 18 |
| Unspecified | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 259 |
| TCM | 64 |
| Therapeutic biologic | 58 |
| 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
73 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 | 4 | 2 | 22 |
| 2 | Risperidone Oral Solution | 4 | 1 | 6 |
| 3 | Calcium Acetate Oral Solution | 4 | 1 | 1 |
| 4 | Aripiprazole Oral Solution | 4 | 1 | 4 |
| 5 | Drotaverine Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 7 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | 维生素B12注射液 · No verified English name | 2 | 2 | 6 |
| 10 | Oxcarbazepine Tablets | 2 | 1 | 4 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 13 | 4 | 13 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 7 | 3 | 0 |
| 5 | Hong Tao Kai Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | CISEN PHARMACEUTICAL CO., LTD. | 5 | 2 | 1 |
| 8 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Hainan Hai Li Pharmaceutical Co., Ltd. romanized | 4 | 4 | 1 |
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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/20Import · Class 2.2 | Tremelimumab注射液 · No verified English nameJXSL2500078 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2500077 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD1613注射液 · No verified English nameJXSL2500076 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/05/20Import · Class 2.4 | 氘可来昔替尼片 · No verified English nameJXHS2500059 | Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD5305 · No verified English nameJXHL2500119 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD5305 · No verified English nameJXHL2500118 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD5305 · No verified English nameJXHL2500117 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD5305 · No verified English nameJXHL2500116 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Generic · Class 3 | Acetylcysteine TabletsCYHS2501825 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2025/05/20Generic · Class 3 | Bumetanide InjectionCYHS2501821 | Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/05/20Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2501818 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/20Generic · Class 3 | Atropine Sulfate InjectionCYHS2501817 | Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/05/20Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2501814 | Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2025/05/20New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2500399 | Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized |
| 2025/05/20New drug · Class 1 | 注射用BC3195 · No verified English nameCXSL2500398 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2025/05/20New drug · Class 1 | 注射用康替唑胺钠 · No verified English nameCXHS2500053 | Shanghai Meng Ke Pharma Co., Ltd. romanized; Hainan Shuang Cheng Pharma Co., Ltd. romanized |
| 2025/05/20New drug · Class 2.2 | 环孢素眼用凝胶 · No verified English nameCXHS2500052 | Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized |
| 2025/05/20New drug · Class 1 | DC411151胶囊 · No verified English nameCXHL2500487 | Hangzhou Minsheng Pharmaceutical Co., Ltd; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2025/05/20New drug · Class 1 | DC411151胶囊 · No verified English nameCXHL2500486 | Hangzhou Minsheng Pharmaceutical Co., Ltd; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2025/05/20New drug · Class 2.4 | 氟[18F]阿洛夫定注射液 · No verified English nameCXHL2500485 | Jiangsu Hua Yi Technology Co., Ltd. romanized |
| 2025/05/19Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2501810 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500397 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500396 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500395 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2500394 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500391 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/05/19New drug · Class 2.2 | QLM2012 · No verified English nameCXHL2500489 | Qilu Pharmaceutical Co., Ltd. |
| 2025/05/19New drug · Class 2.2 | QLM2012 · No verified English nameCXHL2500488 | Qilu Pharmaceutical Co., Ltd. |
| 2025/05/17Import · Class 1 | AMG 890 · No verified English nameJXHL2500115 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/05/17Import · Class 1 | AMG 890 · No verified English nameJXHL2500114 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
92 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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