YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 343 drug applications between 21 October 2024 and 27 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 78 drug names.
2024/10/21 – 2024/10/27
- New acceptances this week
- 343
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 1
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
343filings, 114 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 114 |
| New drug | 44 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| TCM | 66 |
| Therapeutic biologic | 40 |
| Biologic | 9 |
| Prophylactic biologic | 7 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 6 | 3 | 60 |
| 2 | Methotrexate Injection | 6 | 1 | 11 |
| 3 | 维生素B6注射液 · No verified English name | 4 | 4 | 10 |
| 4 | Crisaborole Ointment | 2 | 2 | 26 |
| 5 | Bilastine Oral Solution | 2 | 2 | 8 |
| 6 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 7 | Famotidine Injection | 2 | 2 | 8 |
| 8 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Lactated Ringer's Injection | 2 | 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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 20 | 14 | 0 |
| 2 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 6 | 1 | 6 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | Sanofi-Aventis Recherche & Développement | 4 | 4 | 0 |
| 7 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | AstraZeneca AB | 4 | 2 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/26Import · Class 1 | Remternetug注射液 · No verified English nameJXSL2400205 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/26Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2403649 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2024/10/26Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2403648 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2024/10/26Generic · Class 3 | 咪达唑仑口服溶液 · No verified English nameCYHS2403647 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/10/26Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2403644 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/10/26Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2403638 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2024/10/26Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403635 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/10/26New drug · Class 2.2 | 注射用泰它西普 · No verified English nameCXSS2400115 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | HB0028注射液 · No verified English nameCXSL2400732 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | HB002.1T注射液 · No verified English nameCXSL2400731 | Zhejiang Hua Hai Bio Technology Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | SHR-4375注射液 · No verified English nameCXSL2400730 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | MAX-10181片 · No verified English nameCXHL2401133 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | MAX-10181片 · No verified English nameCXHL2401132 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/26New drug · Class 1 | MAX-10181片 · No verified English nameCXHL2401131 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/25Import · Class 1 | S095029 · No verified English nameJXSL2400204 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD |
| 2024/10/25Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2400258 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/25Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2400257 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/25Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403632 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/10/25Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403631 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2403629 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403625 | Xian An Jian Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Progesterone InjectionCYHS2403624 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | 羧甲司坦干糖浆 · No verified English nameCYHS2403623 | Kang Zhi Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2403622 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | 法罗培南钠片 · No verified English nameCYHS2403621 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/10/25Generic · Class 3 | Famotidine InjectionCYHS2403617 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Epinephrine InjectionCYHS2403616 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Sucralfate Oral SuspensionCYHS2403610 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | Sucralfate Oral SuspensionCYHS2403608 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2024/10/25Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403607 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
78 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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